(am j obstet gynecol [ta] OR obstet gynecol [ta] OR br j obstet gynaecol [ta] OR acta obstet gynecol scand [ta] OR j reprod med [ta] ) AND ("clinical trials"[MeSH Terms] OR "clinical trial"[Text Word] OR "meta analysis"[MeSH Terms] OR "meta analysis"[Text Word] OR "guideline"[All Fields] OR "consensus development conference"[All Fields] OR systematic [sb]) (only with abstract)

5279 articles - 08.09.10


1: Am J Obstet Gynecol. 2010 Sep;203(3):248.e1-9.

Failure of 17-hydroxyprogesterone to reduce neonatal morbidity or prolong triplet pregnancy: a double-blind, randomized clinical trial.

Combs CA, Garite T, Maurel K, Das A, Porto M; Obstetrix Collaborative Research Network.

Obstetrix Medical Group, Sunrise, FL.

OBJECTIVE: To test whether 17 alpha-hydroxyprogesterone caproate (17P) will reduce neonatal morbidity by increasing gestational age at delivery in triplet pregnancies. STUDY DESIGN: Double-blind, randomized clinical trial. Mothers carrying trichorionic-triamniotic triplets were randomly assigned (in a 2:1 ratio) to weekly injections of 250 mg of 17P or placebo, starting at 16-22 weeks and continued until 34 weeks. Primary outcome was composite neonatal morbidity. RESULTS: Fifty-six women were randomized to 17P and 25 to placebo. Composite neonatal morbidity occurred with similar frequency in the 17P and placebo groups (38% vs 41%, respectively; P = .71). Mean gestational age at delivery was not affected by 17P (31.9 vs 31.8 weeks; P = .36). There were 13 midtrimester fetal losses with 17P vs none with placebo (P < .02). CONCLUSION: In triplet pregnancy, prophylactic treatment with 17P did not reduce neonatal morbidity or prolong gestation but was associated with increased midtrimester fetal loss. Copyright (c) 2010 Mosby, Inc. All rights reserved.

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20816146&dopt=ExternalLink

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PMID: 20816146 [PubMed - in process]

2: Acta Obstet Gynecol Scand. 2010 Sep;89(9):1162-7.

An association between cytomegalovirus infection and pre-eclampsia: a case-control study and data synthesis.

Xie F, Hu Y, Magee LA, Money DM, Patrick DM, Krajden M, Thomas E, von Dadelszen P; Toxemia Study Group.

Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, Canada.

OBJECTIVE: Pre-eclampsia shares several similarities with atherosclerotic heart disease. We explored whether, like atherosclerosis, there is a potential link between cytomegalovirus (CMV) infection and pre-eclampsia. DESIGN: CMV IgG, IgM and IgA antibodies were determined by enzyme-linked immunosorbent assays in serums from pre-eclampsia (n = 78), normotensive intrauterine growth restriction (nIUGR) (n = 30) and normal pregnancy controls (n = 109). Data were analyzed by chi-squared, Kruskal-Wallis ANOVA and Mann-Whitney U-tests. Further, we conducted a comprehensive review of published studies on the relation between CMV infection and pre-eclampsia. Risk ratios (RRs) and 95% confidence interval (CI), according to CMV infection status, were calculated using Review Manager. MAIN OUTCOME MEASURES: Women with pre-eclampsia had increased CMV IgG seropositivity compared with nIUGR (p < 0.01) and normal pregnancy controls (p < 0.01). In addition, CMV IgG antibody level was higher in pre-eclampsia than normal pregnancy controls (p < 0.001). No difference was observed in CMV IgM or IgA among study groups. Data synthesis revealed that women with CMV infection were at higher risk in the development of pre-eclampsia, compared with women without CMV infection. Combined results for six studies yielded a RR of 1.5 (95% CI 1.2-1.9). CONCLUSION: CMV infection seems to affect the occurrence of pre-eclampsia. Evaluation of the relation between CMV infection and pre-eclampsia may provide mechanistic insights into pre-eclampsia-related inflammation.

Publication Types: Research Support, Non-U.S. Gov't

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20804342&dopt=ExternalLink

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PMID: 20804342 [PubMed - in process]

3: Am J Obstet Gynecol. 2010 Aug 23; [Epub ahead of print]

Oral hypoglycemic agents vs insulin in management of gestational diabetes: a systematic review and metaanalysis.

Dhulkotia JS, Ola B, Fraser R, Farrell T.

Department of Obstetrics and Gynecology, Jessop Wing, Sheffield Teaching Hospital National Health Service Trust, Sheffield, England, United Kingdom.

OBJECTIVE: The objective of this review was to provide pooled estimates of randomized controlled trials comparing the effects of oral hypoglycemic agents with insulin in achieving glycemic control and to study the maternal and perinatal outcomes in gestational diabetes mellitus. STUDY DESIGN: A protocol for the study was developed. All metaanalyses were performed using Stats Direct statistical software (Stats Direct Ltd, Cheshire, UK). RESULTS: Six studies comprising 1388 subjects were analyzed. No significant differences were found in maternal fasting (weighted mean difference [WMD], 1.31; 95% confidence interval [CI], 0.81-3.43) or postprandial (WMD, 0.80; 95% CI, -3.26 to 4.87) glycemic control. Use of oral hypoglycemic agents (OHAs) was not associated with risk of neonatal hypoglycemia (odds ratio [OR], 1.59; 95% CI, 0.70-3.62), increased birthweight (WMD, 56.11; 95% CI, -42.62 to 154.84), incidence of caesarean section (OR, 0.91; 95% CI, -0.68 to 1.22), or incidence of large-for-gestational-age babies (OR, 1.01; 95% CI, 0.61-1.68). CONCLUSION: Our study demonstrates that there are no differences in glycemic control or pregnancy outcomes when OHAs were compared with insulin. Copyright (c) 2010 Mosby, Inc. All rights reserved.

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20739011&dopt=ExternalLink

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PMID: 20739011 [PubMed - as supplied by publisher]

4: Obstet Gynecol. 2010 Sep;116(3):694-700.

Adherence to evidence-based guidelines for preoperative testing in women undergoing gynecologic surgery.

St Clair CM, Shah M, Diver EJ, Lewin SN, Burke WM, Sun X, Herzog TJ, Wright JD.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, New York, USA.

OBJECTIVE: To examine adherence to evidence-based recommendations for preoperative testing and health care costs associated with excessive testing. METHODS: An institutional review of women who underwent gynecologic surgery between 2005 and 2007 was performed. Data on the type of surgery, age, comorbidities, and perioperative testing was extracted. We noted the preoperative performance of chest X-ray, electrocardiogram, metabolic panel, complete blood count, coagulation studies, liver function tests, and urinalysis. Each test was classified as being guideline-based (appropriate) or non-guideline-based (inappropriate) as described by the National Institute of Clinical Excellence perioperative guidelines. RESULTS: A total of 1,402 patients were identified. Ninety-five percent of patients underwent all of the guideline-recommended preoperative testing. Ninety percent of women underwent at least one nonindicated preoperative test. None of the 749 urinalyses, 407 liver function tests, or 1,046 coagulation studies performed was appropriate. Ninety-nine percent of the 427 chest X-rays ordered were inappropriate. Only 17% of metabolic panels, 36% of electrocardiograms, and 29% of complete blood counts were in accordance with evidence-based guidelines. Inappropriate perioperative tests led to a direct cost of more than $418,000. Of the inappropriate tests ordered, abnormalities were noted frequently but rarely changed management. CONCLUSION: Adherence to evidence-based recommendations for preoperative testing is poor. Inappropriate preoperative tests represent a major health care expenditure. LEVEL OF EVIDENCE: III.

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733454&dopt=ExternalLink

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PMID: 20733454 [PubMed - in process]

5: Obstet Gynecol. 2010 Sep;116(3):659-66.

The active implementation of pregnancy hypertension guidelines in British Columbia.

von Dadelszen P, Sawchuck D, McMaster R, Douglas MJ, Lee SK, Saunders S, Liston RM, Magee LA; Translating Evidence-Based Surveillance and Treatment Strategies (TESS) Group.

Departments of Obstetrics and Gynaecology, Anesthesiology, Pharmacology and Therapeutics, and Medicine, School of Public and Population Health, Child and Family Research Institute, and Faculty of Medicine, University of British Columbia, and the BC Perinatal Health Program, Vancouver, British Columbia, Canada. pvd@cw.bc.ca

OBJECTIVE: To reduce maternal and perinatal morbidity and mortality associated with the hypertensive disorders of pregnancy by using an active model of guideline implementation. METHODS: This study used a preintervention and postintervention cohort comparison design. We interrogated the British Columbia Perinatal Database Registry for 6 years of existing prospectively gathered data (fiscal years 2000-2001 to 2005-2006), introduced the hypertensive disorders of pregnancy guidelines, and assessed the incidence of the combined adverse maternal and perinatal outcomes for the next 2 years (fiscal years 2006-2007 and 2007-2008). The combined adverse maternal outcome was maternal death, life-threatening, or life-altering complications. The combined perinatal outcome included the severe complications of prematurity and hypoxic-ischemic encephalopathy. RESULTS: Eighteen thousand seventy-six women were diagnosed with hypertensive disorder of pregnancy in British Columbia from 2000-2001 to 2007-2008. Outcomes were compared preguideline (n=13,150 deliveries) and postguideline (n=4,926 deliveries) implementation. The incidence of the combined adverse maternal outcome decreased from 3.1% to 1.9% (relative risk 0.60, 95% confidence interval 0.48-0.75). There was a concomitant fall in the incidence of the combined adverse perinatal outcome. CONCLUSION: The active introduction of standardized management of women with a hypertensive disorder of pregnancy is associated with reduced maternal and perinatal risk. LEVEL OF EVIDENCE: II.

Publication Types: Research Support, Non-U.S. Gov't

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733449&dopt=ExternalLink

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PMID: 20733449 [PubMed - in process]

6: Obstet Gynecol. 2010 Sep;116(3):653-8.

Vitamin C and e supplementation to prevent spontaneous preterm birth: a randomized controlled trial.

Hauth JC, Clifton RG, Roberts JM, Spong CY, Myatt L, Leveno KJ, Pearson GD, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU).

Departments of Obstetrics and Gynecology at the University of Alabama at Birmingham, Birmingham, Alabama, USA. jchauth@uab.edu

OBJECTIVE: To estimate whether maternally administered vitamins C and E lower the risk of spontaneous preterm birth. METHODS: This is a secondary analysis of a randomized, double-masked, placebo-controlled trial in nulliparous women at low-risk administered 1,000 mg vitamin C and 400 international units vitamin E or placebo daily from 9 to 16 weeks of gestation until delivery. Outcomes include preterm birth attributable to premature rupture of membranes (PROM) and total spontaneous preterm births (spontaneous preterm birth attributable to PROM or spontaneous labor). RESULTS: Of the 10,154 women randomized, outcome data were available for 9,968 (4,992 vitamin group and 4,976 placebo group). A total of 1,038 women (10.4%) delivered preterm, of whom 698 (7.0%) had spontaneous preterm birth. A spontaneous preterm birth occurred in 356 women (7.1%) assigned to daily vitamin C and E supplementation and in 342 (6.9%) assigned to placebo. There were 253 women (2.5%) who delivered after preterm PROM and 445 (4.5%) after a spontaneous preterm labor. In women supplemented with vitamins C and E, births attributed to preterm PROM were similar at less than 37 and 35 weeks of gestation, but births were less frequent before 32 weeks of gestation (0.3% compared with 0.6%, adjusted odds ratio 0.3-0.9). However, total spontaneous preterm births across gestation in women supplemented with vitamins C and E or a placebo were similar. CONCLUSION: Maternal supplementation with vitamins C and E beginning at 9 to 16 weeks of gestation in nulliparous women at low risk did not reduce spontaneous preterm births. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00135707. LEVEL OF EVIDENCE: I.

Publication Types: Research Support, N.I.H., Extramural

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733448&dopt=ExternalLink

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PMID: 20733448 [PubMed - in process]

7: Obstet Gynecol. 2010 Sep;116(3):641-52.

Outcomes from leiomyoma therapies: comparison with normal controls.

Spies JB, Bradley LD, Guido R, Maxwell GL, Levine BA, Coyne K.

Georgetown University Hospital Department of Radiology, Washington, DC, USA. spiesj@gunet.georgetown.edu

OBJECTIVE: To assess the severity of symptoms caused by uterine leiomyomas, their effect on health-related quality of life, and the change after treatment compared with a normal control group. METHODS: A multicenter nonrandomized prospective study was completed assessing 12-month outcomes from three leiomyoma treatments. Outcome measures included the Uterine Fibroid Symptom and Quality of Life and the Short Form 36 questionnaires. Women scheduled for hysterectomy, myomectomy, or uterine artery embolization were recruited, as well as normal control group members. Questionnaires were completed at baseline and at 6 and 12 months posttreatment. Baseline characteristics were summarized using descriptive statistics. General linear models were used to examine differences among the patient groups. RESULTS: A total of 375 patients completed baseline enrollment: 101 normal, 107 embolization, 61 myomectomy, and 106 hysterectomy. At baseline, the mean Uterine Fibroid Symptom and Quality of Life Symptom Severity score for women in the normal control group was 15.3 (+/-14.5) and 64.8 (+/-20) for the leiomyoma patients (P<.001). At 6 and 12 months, the mean Symptom score for women in the normal control group was unchanged, while the leiomyoma treatment group score reduced to a mean of 17.8 (+/-17.5) at 12 months. Similar magnitude changes occurred among the Uterine Fibroid Symptom and Quality of Life health-related quality of life subscale scores for the normal control group members and leiomyoma patients. At 12 months, the hysterectomy group reported significantly lower symptoms and better health-related quality of life than the other two therapies (P<.001). CONCLUSION: At 12 months after treatment, all three leiomyoma therapies resulted in substantial symptom relief, to near normal levels, with the greatest improvement after hysterectomy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00390494. LEVEL OF EVIDENCE: II.

Publication Types: Research Support, U.S. Gov't, Non-P.H.S.

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733447&dopt=ExternalLink

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PMID: 20733447 [PubMed - in process]

8: Obstet Gynecol. 2010 Sep;116(3):633-40.

Using daily text-message reminders to improve adherence with oral contraceptives: a randomized controlled trial.

Hou MY, Hurwitz S, Kavanagh E, Fortin J, Goldberg AB.

Boston University School of Medicine, Boston, Massachusetts, USA. Melody.hou@bmc.org

OBJECTIVE: To estimate whether women receiving daily text-message reminders have increased oral contraceptive pill adherence compared with women not receiving reminders. METHODS: This randomized controlled trial estimated whether there was an effect of daily text-message reminders on oral contraceptive pill adherence of new oral contraceptive pill users. Pill-taking was tracked for 3 months by an electronic monitoring device with wireless data collection. During the study period, participants assigned the intervention received a daily reminder text message. Eighty-two women were assigned randomly to detect a 1.6+/-2.0 pill difference (90% power, 5% alpha, 15% dropout). RESULTS: Participants were 79% white, non-Hispanic, 99% high school graduates, and 99% nulliparous with a mean age of 22 years. Most reported condom use with past coital activity, and more than half reported prior emergency contraception use. The mean number of missed pills per cycle did not differ significantly between the groups: 4.9+/-3.0 for the text-message group and 4.6+/-3.5 for the control group (P=.60). The number of missed pills per cycle increased over the course of the study, but this pattern did not increase differentially between the groups. Adherence recorded by the electronic monitoring device indicated much poorer adherence than that recorded by patient diaries. Despite poor pill-taking, there were no pregnancies. CONCLUSION: Daily text-message reminders did not improve oral contraceptive pill adherence. Although the lack of benefit may be attributed to the frequent use of alternative reminder systems in the control group, the rate of missed pills when measured objectively was still very high in both groups. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00733707. LEVEL OF EVIDENCE: I.

Publication Types: Research Support, Non-U.S. Gov't

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733446&dopt=ExternalLink

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PMID: 20733446 [PubMed - in process]

9: Obstet Gynecol. 2010 Sep;116(3):625-32.

Levonorgestrel-releasing intrauterine system or medroxyprogesterone for heavy menstrual bleeding: a randomized controlled trial.

Kaunitz AM, Bissonnette F, Monteiro I, Lukkari-Lax E, Muysers C, Jensen JT.

Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, USA. Andrew.kaunitz@jax.ufl.edu

OBJECTIVE: To compare the efficacy and safety of the levonorgestrel-releasing intrauterine system and oral medroxyprogesterone acetate in the treatment of idiopathic heavy menstrual bleeding. METHODS: In this multicenter, randomized, controlled study, women aged 18 years or older with heavy menstrual bleeding (menstrual blood loss 80 mL or more per cycle) were randomly assigned to six cycles of treatment with either levonorgestrel-releasing intrauterine system or oral medroxyprogesterone acetate (10 mg daily for 10 days beginning on day 16 of each cycle). The primary efficacy variables were the absolute change in menstrual blood loss from baseline to end of study and the proportion of women with successful treatment (defined as menstrual blood loss less than 80 mL and a 50% or greater reduction in menstrual blood loss from baseline). RESULTS: Of 807 women screened, 165 were randomly assigned to treatment (levonorgestrel-releasing intrauterine system n=82, oral medroxyprogesterone acetate n=83). At the end of the study, the absolute reduction in median menstrual blood loss was significantly greater in the levonorgestrel-releasing intrauterine system group (-128.8 mL, range -393.6 to +1242.2 mL) than in the medroxyprogesterone acetate arm (-17.8 mL, range -271.5 to +78.6 mL, P < .001), and the proportion of women with successful treatment was significantly higher for the levonorgestrel-releasing intrauterine system (84.8%) than for medroxyprogesterone acetate (22.2%, P < .001). CONCLUSION: In women with idiopathic heavy menstrual bleeding, the levonorgestrel-releasing intrauterine system reduces menstrual blood loss more effectively and has a higher likelihood of treatment success than oral medroxyprogesterone acetate. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00360490. LEVEL OF EVIDENCE: I.

Publication Types: Research Support, Non-U.S. Gov't

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733445&dopt=ExternalLink

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PMID: 20733445 [PubMed - in process]

10: Obstet Gynecol. 2010 Sep;116(3):619-24.

Using intraumbilical vein injection of oxytocin in routine practice with active management of the third stage of labor: a randomized controlled trial.

Gungorduuk K, Asicioglu O, Besimoglu B, Guungorduuk OC, Yildirm G, Ark C, Tekirdag AI.

Mardin Women and Children Hospital, Mardin, Turkey. maidenkemal@yahoo.com

OBJECTIVE: To estimate the efficacy of the routine use of intraumbilical vein injection of oxytocin with active management of the third stage of labor in reducing blood loss and length of the third stage. METHODS: In this prospective, randomized, double-blind trial, 412 women undergoing vaginal delivery who did not have risk factors for postpartum hemorrhage were randomly allocated to receive either 20 international units oxytocin diluted with 26 mL saline (n=207) or 30 mL saline (n=205) by intraumbilical vein injection. Active management of the third stage of labor (prophylactic injection of 10 international units oxytocin within 2 minutes of birth, early clamping of the umbilical cord, and controlled cord traction) was used in both groups. The primary outcome was mean blood loss during the third and fourth stages of labor. RESULTS: The mean estimated blood loss was significantly lower in women treated with oxytocin compared with women in the placebo group (195.3+/-81.0 mL compared with 288.3+/-134.1 mL, respectively; P<.001). The third stage of labor was significantly shorter in the oxytocin group than in the placebo group (4.5+/-1.6 minutes compared with 7.9+/-3.4 minutes, respectively; P<.001). The percentages of placentas remaining undelivered beyond 15 minutes were 0% in the oxytocin group and 4.4% in the placebo group (P=.002). CONCLUSION: The use of intraumbilical injection of oxytocin with the active management of the third stage of labor significantly reduced postpartum blood loss and the duration of the third stage. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01094028. LEVEL OF EVIDENCE: I.

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733444&dopt=ExternalLink

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PMID: 20733444 [PubMed - in process]

11: Obstet Gynecol. 2010 Sep;116(3):612-8.

Titrated oral misoprostol solution compared with intravenous oxytocin for labor augmentation: a randomized controlled trial.

Ho M, Cheng SY, Li TC.

Department of Obstetrics and Gynecology, China Medical University Hospital, Taichung, Taiwan.

OBJECTIVE: To compare titrated oral misoprostol to intravenous oxytocin for labor augmentation among women at 36 to 42 weeks of gestation with spontaneous onset of active labor. METHODS: Women meeting the general selection criteria with regular contractions and an effaced cervix dilated between 3 and 9 cm, and who had inadequate uterine contractions (two or fewer contractions every 10 minutes) during the first stage of labor, were randomly assigned to titrated oral misoprostol or intravenous oxytocin. Augmentation-to-vaginal delivery interval and vaginal delivery within 12 or 24 hours were the primary outcomes. The data were analyzed by intention to treat. RESULTS: Of the 231 women, 118 (51.1%) were randomized to titrated oral misoprostol and 113 (48.9%) to titrated intravenous oxytocin. The median interval from the start of augmentation to vaginal delivery was 5.22 hours (3.77-8.58 hours, 25th-75th percentile) in the misoprostol group, and 5.20 hours (3.23-6.50 hours, 25th-75th percentile) in the intravenous oxytocin group (P=.019). Complete vaginal delivery occurred within 12 hours for 92 women (78.0%) in the misoprostol group and for 97 women (85.8%) in the oxytocin group (P=.121; relative risk 0.91, 95% confidence interval 0.80-1.03). There were no significant differences between the two groups who delivered vaginally within 24 hours. Side effects and neonatal outcomes also did not differ between the two groups. CONCLUSION: Labor augmentation with titrated oral misoprostol or intravenous oxytocin resulted in similar rates of vaginal delivery within 12 and 24 hours. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00695331. LEVEL OF EVIDENCE: I.

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733443&dopt=ExternalLink

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PMID: 20733443 [PubMed - in process]

12: Obstet Gynecol. 2010 Sep;116(3):583-93.

Oral desipramine and topical lidocaine for vulvodynia: a randomized controlled trial.

Foster DC, Kotok MB, Huang LS, Watts A, Oakes D, Howard FM, Poleshuck EL, Stodgell CJ, Dworkin RH.

Departments of Obstetrics and Gynecology, Biostatistics, Anesthesiology and Neurology, and Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York 14642, USA. david_foster@urmc.rochester.edu

OBJECTIVE: To estimate the efficacy of common treatments for vulvodynia: topical lidocaine monotherapy, oral desipramine monotherapy, and lidocaine-desipramine combined therapy. METHODS: A 12-week randomized, double-blinded, placebo-controlled trial was conducted on 133 vulvodynia-afflicted women assigned to four treatment arms: placebo tablets-placebo cream, desipramine tablets-placebo cream, placebo tablets-lidocaine cream, and desipramine tablets-lidocaine cream. The tampon test was selected as primary end point using a modified intention-to-treat analysis. Twelve secondary end points were also examined. At completion of the 12-week randomized phase, women were examined "open label" through 52 weeks postrandomization. RESULTS: All treatment arms reported substantial tampon-test pain reduction: 33% reduction placebo cream-placebo tablet, 20% reduction lidocaine cream-placebo tablet, 24% reduction placebo cream-desipramine tablet, and 36% reduction lidocaine cream-desipramine tablet. Compared with placebo, we found no significant difference in tampon-test pain reduction with desipramine (t=0.90; P=.37) or lidocaine (t=1.27; P=.21). Of the remaining 12 outcome measures, only the Index of Sexual Satisfaction, improved with desipramine compared with placebo (t=-2.81; P=.006). During the open-label phase, women undergoing vestibulectomy surgery reported significantly improved pain as measured by cotton swab test and the McGill Pain Scale compared with nonsurgical alternatives. CONCLUSION: Oral desipramine and topical lidocaine, as monotherapy or in combination, failed to reduce vulvodynia pain more than placebo. Placebo or placebo-independent effects are behind the substantial pain improvement seen in all treatment allocations. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00276068. LEVEL OF EVIDENCE: I.

Publication Types: Research Support, N.I.H., Extramural

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733439&dopt=ExternalLink

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PMID: 20733439 [PubMed - in process]

13: Obstet Gynecol. 2010 Aug;116(2 Pt 1):450-63.

ACOG Practice bulletin no. 115: Vaginal birth after previous cesarean delivery.

American College of Obstetricians and Gynecologists.

Trial of labor after previous cesarean delivery (TOLAC)* provides women who desire a vaginal delivery with the possibility of achieving that goal--a vaginal birth after cesarean delivery (VBAC). In addition to fulfilling a patient's preference for vaginal delivery, at an individual level VBAC is associated with decreased maternal morbidity and a decreased risk of complications in future pregnancies. At a population level, VBAC also is associated with a decrease in the overall cesarean delivery rate (1, 2). Although TOLAC is appropriate for many women with a history of a cesarean delivery, several factors increase the likelihood of a failed trial of labor, which compared with VBAC, is associated with increased maternal and perinatal morbidity (3-5). Assessment of individual risks and the likelihood of VBAC is, therefore, important in determining who are appropriate candidates for TOLAC. The purpose of this document is to review the risks and benefits of TOLAC in various clinical situations and provide practical guidelines for managing and counseling patients who will give birth after a previous cesarean delivery.

Publication Types: Practice Guideline

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20664418&dopt=ExternalLink

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PMID: 20664418 [PubMed - indexed for MEDLINE]

14: Obstet Gynecol. 2010 Aug;116(2 Pt 1):402-14.

Prevention of preeclampsia and intrauterine growth restriction with aspirin started in early pregnancy: a meta-analysis.

Bujold E, Roberge S, Lacasse Y, Bureau M, Audibert F, Marcoux S, Forest JC, Giguere Y.

Department of Obstetrics and Gynecology, Faculty of Medicine, Laval University, Quebec, Canada. emmanuel.bujold@crchul.ulaval.ca

OBJECTIVE: To estimate the effect of low-dose aspirin started in early pregnancy on the incidence of preeclampsia and intrauterine growth restriction (IUGR). DATA SOURCES: A systematic review and meta-analysis were performed through electronic database searches (PubMed, Cochrane, Embase). METHODS OF STUDY SELECTION: Randomized controlled trials of pregnant women at risk of preeclampsia who were assigned to receive aspirin or placebo (or no treatment) were reviewed. Secondary outcomes included IUGR, severe preeclampsia and preterm birth. The effect of aspirin was analyzed as a function of gestational age at initiation of the intervention (16 weeks of gestation or less, 16 weeks of gestation or more). TABULATION, INTEGRATION, AND RESULTS: Thirty-four randomized controlled trials met the inclusion criteria, including 27 studies (11,348 women) with follow-up for the outcome of preeclampsia. Low-dose aspirin started at 16 weeks or earlier was associated with a significant reduction in preeclampsia (relative risk [RR] 0.47, 95% confidence interval [CI] 0.34-0.65, prevalence in 9.3% treated compared with 21.3% control) and IUGR (RR 0.44, 95% CI 0.30-0.65, 7% treated compared with 16.3% control), whereas aspirin started after 16 weeks was not (preeclampsia: RR 0.81, 95% CI 0.63-1.03, prevalence in 7.3% treated compared with 8.1% control; IUGR: RR 0.98, 95% CI 0.87-1.10, 10.3% treated compared with 10.5% control). Low-dose aspirin started at 16 weeks or earlier also was associated with a reduction in severe preeclampsia (RR 0.09, 95% CI 0.02-0.37, 0.7% treated compared with 15.0% control), gestational hypertension (RR 0.62, 95% CI 0.45-0.84, 16.7% treated compared with 29.7% control), and preterm birth (RR 0.22, 95% CI 0.10-0.49, 3.5% treated compared with 16.9% control). Of note, all studies for which aspirin had been started at 16 weeks or earlier included women identified to be at moderate or high risk for preeclampsia. CONCLUSION: Low-dose aspirin initiated in early pregnancy is an efficient method of reducing the incidence of preeclampsia and IUGR.

Publication Types: Meta-Analysis Research Support, Non-U.S. Gov't

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20664402&dopt=ExternalLink

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PMID: 20664402 [PubMed - indexed for MEDLINE]

15: Obstet Gynecol. 2010 Aug;116(2 Pt 1):393-401.

Inflammatory cytokines and spontaneous preterm birth in asymptomatic women: a systematic review.

Wei SQ, Fraser W, Luo ZC.

Department of Obstetrics and Gynecology, Sainte-Justine Hospital, University of Montreal, Quebec, Canada.

OBJECTIVE: To estimate the association between inflammatory cytokines and the risk of spontaneous preterm birth in asymptomatic women. DATA SOURCES: We searched electronic databases of the human literature in PubMed, EMBASE, and the Cochrane Library up to February 2010 using the following key words: "preterm/pre-term + (birth/delivery)" and "cytokine" or "inflammation/inflammatory + marker/biomarker." METHODS OF STUDY SELECTION: We included observational studies that reported the association between common inflammatory cytokines and spontaneous preterm birth as an outcome in asymptomatic women. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using fixed and random effects models. TABULATION, INTEGRATION, AND RESULTS: Seventeen primary studies comprising 6,270 participants met the inclusion criteria. Spontaneous preterm birth was strongly associated with increased levels of interleukin-6 (IL-6) in midtrimester cervicovaginal fluid (OR 3.05, 95% CI 2.00-4.67) (number needed to treat=7 for identifying an additional preterm delivery) and amniotic fluid (OR 4.52, 95% CI 2.67-7.65) (number needed to treat=7), but there was no association in plasma specimen (OR 1.5, 95% CI 0.7-3.0). Spontaneous preterm birth was strongly associated with increased C-reactive protein (CRP) levels in midtrimester amniotic fluid (OR 7.85, 95% CI 3.88-15.87) (number needed to treat=3), but the association was weak in plasma specimen (OR 1.53, 95% CI 1.22-1.90). There were insufficient data (fewer than three studies) for meta-analysis in other inflammatory cytokines. CONCLUSION: Inflammatory cytokine IL-6 in cervicovaginal fluid and IL-6 and CRP in amniotic fluid but not in plasma are strongly associated with spontaneous preterm birth in asymptomatic women, suggesting that inflammation at the maternal-fetal interface, rather than systemic inflammation, may play a major role in the etiology of such spontaneous preterm births.

Publication Types: Research Support, Non-U.S. Gov't Review

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20664401&dopt=ExternalLink

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PMID: 20664401 [PubMed - indexed for MEDLINE]

16: Obstet Gynecol. 2010 Aug;116(2 Pt 1):387-92.

Chorioamnionitis and cerebral palsy: a meta-analysis.

Shatrov JG, Birch SC, Lam LT, Quinlivan JA, McIntyre S, Mendz GL.

School of Medicine, Sydney, The University of Notre Dame Australia and Cerebral Palsy Institute, Darlinghurst, New South Wales, Australia.

OBJECTIVE: To examine the relationships between clinical or histological chorioamnionitis and cerebral palsy using a meta-analysis approach. DATA SOURCES: A systematic review of the literature appeared in PubMed between 2000 and 2009 was conducted using the search terms "cerebral palsy" and "infection," with broad-scope variations in terminology of "white matter damage," "periventricular leukomalacia," "cystic periventricular leukomalacia," "chorioamnionitis," "intrauterine infection," "intraventricular hemorrhage," "funisitis," "fetal inflammatory response," "early neonatal sepsis," "neurological impairment," "virus," "bacteria," "fungi," and "protozoa," with variations of suffixes (eg, "viral," "bacterial," "fungal," "protozoan," etc), and "urinary tract infection," "bacterial vaginosis," "bacteriuria," and "cytokines." The related key words "gestational age," "small for gestational age," "preterm," and "low birth weight" also were added to the search terms. Only studies published in English were included. METHODS: Three hundred eight articles were retrieved and systematically reviewed independently by two authors. Application of four inclusion criteria led to 15 studies being considered for data abstraction. An exposure was considered relevant if it met the established criteria for clinical or histological chorioamnionitis. The outcome was a diagnosis of cerebral palsy in accordance with established criteria. RESULTS: The data were abstracted onto standard forms, correlated according to eight characteristics, and tabulated. Twelve of the 15 studies contained information on the association between clinical chorioamnionitis and cerebral palsy, and eight studies included information on the association between histological chorioamnionitis and cerebral palsy. The results indicated that there were significant associations between clinical chorioamnionitis or histological chorioamnionitis and cerebral palsy, for clinical chorioamnionitis (chi1=13.91; P<.001) with a pooled odds ratio of 2.42 (95% confidence interval 1.52-3.84), and for histological chorioamnionitis (chi1=6.86; P=.009) with a pooled odds ratio of 1.83 (95% confidence interval, 1.17-2.89). The data suggested increased risks of 140% and 80% for neonates exposed to clinical chorioamnionitis or histological chorioamnionitis, respectively. CONCLUSION: The significant association of clinical or histological chorioamnionitis with cerebral palsy suggested that clinical strategies to prevent or reduce chorioamnionitis would lead to a reduction in cerebral palsy. The culture techniques currently used to diagnose the presence of pathogenic microorganisms during pregnancy need to improve, both in their methodology and in the length of time they require.

Publication Types: Meta-Analysis Research Support, Non-U.S. Gov't Review

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20664400&dopt=ExternalLink

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PMID: 20664400 [PubMed - indexed for MEDLINE]

17: Obstet Gynecol. 2010 Aug;116(2 Pt 1):355-64.

Prevalence of parental thrombophilic defects after fetal death and relation to cause.

Korteweg FJ, Erwich JJ, Folkeringa N, Timmer A, Veeger NJ, Ravise JM, Holm JP, van der Meer J.

Department of Obstetrics, Division of Haemostasis, Trial Coordination Center, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. f.j.korteweg@og.umcg.nl

OBJECTIVE: To estimate whether parental thrombophilic defects after fetal death, either acquired or inherited, were more prevalent than in the normal population and to estimate associations between these thrombophilic defects and different fetal death causes. METHODS: In a multicenter, prospective cohort study of 750 fetal deaths, we tested couples for antithrombin, protein C, total and free protein S, and von Willebrand factor (vWF) plasma levels. Mothers' values were compared with reference values in gestational age-matched healthy pregnant women, and fathers were compared with healthy men. Prevalence of factor V Leiden, prothrombin G20210A mutation, and lupus anticoagulant were compared with the normal population. A panel classified death cause. RESULTS: More women with fetal death had decreased antithrombin (16.8%, P<.001) and protein C (4.0%, P=.03) and increased vWF (15.5%, P<.001) plasma levels than healthy pregnant women (2.5%). However, compared with normal ranges in the nonpregnant population, we only observed more women with increased vWF (12.4%, P<.001). More fathers had decreased free protein S (6.3%, P<.001) and elevated vWF (12.1%, P<.001) than healthy men (2.5%). Prevalence of inherited thrombophilias was not higher in couples with fetal death than in the population. Neither inherited nor acquired maternal or paternal thrombophilic defects were associated with the main cause of death. Of placental causes, abruption and infarction were associated with acquired maternal defects. CONCLUSION: Except for vWF and paternal free protein S, acquired and inherited thrombophilic defects were not more prevalent after fetal death. Routine thrombophilia testing after fetal death is not advised. LEVEL OF EVIDENCE: II.

Publication Types: Clinical Trial Multicenter Study Research Support, Non-U.S. Gov't

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20664396&dopt=ExternalLink

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PMID: 20664396 [PubMed - indexed for MEDLINE]

18: Obstet Gynecol. 2010 Aug;116(2 Pt 1):344-54.

Interpretation of amniotic fluid white blood cell count in "bloody tap" amniocenteses in women with symptoms of preterm labor.

Abdel-Razeq SS, Buhimschi IA, Bahtiyar MO, Rosenberg VA, Dulay AT, Han CS, Werner EF, Thung S, Buhimschi CS.

Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, Connecticut, USA.

OBJECTIVE: To estimate whether blood-contaminated amniotic fluid affects the performance of white blood cell (WBC) count in diagnosing intraamniotic inflammation and infection. METHODS: Three hundred fifty-seven consecutive women pregnant with singletons undergoing amniocentesis to rule out infection were enrolled prospectively. A "bloody tap" was defined as a red blood cell (RBC) count of 1,000 cells/mm or more. Proteomics analysis of amniotic fluid was used in this study as the standard for diagnosing inflammation. Infection was confirmed by positive amniotic fluid culture. An amniotic fluid WBC count correction formula was computed using maternal WBC count, hematocrit, and mean corpuscular volume. RESULTS: The prevalence of a bloody tap amniocentesis was 22% (77 of 357). In the absence of inflammation, the amniotic fluid WBC count was significantly higher in bloody tap (median [interquartile range] 18 [9-58] cells/mm) compared with non-bloody tap specimens (4 [1-10] cells/mm; P<.001). The correction formula reversed this difference to a nonsignificant level (bloody tap 0 [0-17] compared with non-bloody tap 3 [1-10] cells/mm; P=.273). In the setting of inflammation, the observed WBC count of bloody tap samples (778 [197-2,062 cells/mm]) was significantly elevated compared with that of the non-bloody tap specimens (616 [105-1,730] cells/mm; P=.023). Correction of the WBC count in bloody tap amniocenteses improved the test accuracy and positive likelihood ratios for inflammation and infection. A correction algorithm was not useful in amniotic fluid specimens with less than 1,000/RBCs/mm or WBC counts more than 1,100 cells/mm. Given the nonlinear relationship between amniotic fluid WBC and RBC, for a rapid correction of WBC count, the number of neutrophils that need to be subtracted from the observed WBC count is variable. CONCLUSION: In the setting of an amniotic fluid sample contaminated with 1,000 RBCs/mm or more, WBC count is a less accurate indicator of inflammation and infection. In such samples, correction of WBC count enhances diagnostic performance for inflammation and infection. LEVEL OF EVIDENCE: II.

Publication Types: Clinical Trial Research Support, N.I.H., Extramural

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20664395&dopt=ExternalLink

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PMID: 20664395 [PubMed - indexed for MEDLINE]

19: Obstet Gynecol. 2010 Aug;116(2 Pt 1):293-303.

Vaginal mesh for prolapse: a randomized controlled trial.

Iglesia CB, Sokol AI, Sokol ER, Kudish BI, Gutman RE, Peterson JL, Shott S.

Washington Hospital Center, Washington, DC, USA.

OBJECTIVE: To present 3-month outcomes of a double-blind, multicenter randomized controlled trial comparing traditional vaginal prolapse surgery without mesh with vaginal surgery with mesh. METHODS: Women with pelvic organ prolapse quantification prolapse stages 2-4 were randomized to vaginal colpopexy repair with mesh or traditional vaginal colpopexy without mesh. The primary outcome measure was objective treatment success (pelvic organ prolapse quantification stage 1 or lower) at 3 months. Secondary outcome measures included quality-of-life variables and complication rates. RESULTS: Sixty-five women were recruited from January 2007 to August 2009, when the study was halted due to predetermined stopping criteria for vaginal mesh erosion at a median follow-up of 9.7 months (range, 2.4-26.7 months). Thirty-two women underwent mesh colpopexy (24 anterior mesh, eight total mesh), and 33 women had vaginal colpopexies without mesh (primarily uterosacral ligament suspension) and concurrent colporrhaphy. There were no statistically significant baseline differences between the mesh and no-mesh groups with respect to demographics, menopausal status, and race. Analysis of the mesh and no-mesh women found no difference with respect to overall recurrence (mesh: 19 [59.4%] compared with no mesh: 24 [70.4%], P=.28). There were five (15.6%) vaginal mesh erosions. Two cystotomies and one blood transfusion occurred in the mesh group only. Subjective cure of bulge symptoms was noted in 93.3% of mesh patients and 100% of no-mesh patients. Furthermore, subjective quality-of-life measurements did not differ between the two groups at baseline or 3 months postoperatively. CONCLUSION: At 3 months, there is a high vaginal mesh erosion rate (15.6%) with no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540. LEVEL OF EVIDENCE: I.

Publication Types: Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20664388&dopt=ExternalLink

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PMID: 20664388 [PubMed - indexed for MEDLINE]

20: Obstet Gynecol. 2010 Aug;116(2 Pt 1):284-92.

Improving urinary incontinence in overweight and obese women through modest weight loss.

Wing RR, Creasman JM, West DS, Richter HE, Myers D, Burgio KL, Franklin F, Gorin AA, Vittinghoff E, Macer J, Kusek JW, Subak LL; Program to Reduce Incontinence by Diet and Exercise.

Miriam Hospital, Providence, Rhode Island 02903, USA.

OBJECTIVE: To examine the relationship between magnitude of weight loss and changes in urinary incontinence frequency. METHODS: Overweight and obese women (N=338) with 10 or more urinary incontinence episodes per week were assigned randomly to an intensive 6-month behavioral weight loss program followed immediately by a 12-month weight maintenance program (intervention; n=226) or to a structured education program (control; n=112). The intervention and control groups were combined to examine the effects of the magnitude of weight loss on changes in urinary incontinence assessed by 7-day voiding diary, pad test, and self-reported satisfaction with change in urinary incontinence. RESULTS: Compared with participants who gained weight (reference), those who lost 5% to less than 10% or 10% or more of their body weight had significantly greater percent reductions in urinary incontinence episodes and were more likely to achieve at least a 70% reduction in the frequency of total and urge urinary incontinence episodes at 6, 12, and 18 months. Satisfaction was also related to magnitude of weight loss; approximately 75% of women who lost 5% to less than 10% of their body weight reported being moderately or very satisfied with their changes in urine leakage. CONCLUSION: Weight losses between 5% and 10% of body weight were sufficient for significant urinary incontinence benefits. Thus, weight loss should be considered as initial treatment for incontinence in overweight and obese women. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00091988. LEVEL OF EVIDENCE: II.

Publication Types: Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20664387&dopt=ExternalLink

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PMID: 20664387 [PubMed - indexed for MEDLINE]

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