Transcervical Foley catheter with and without extraamniotic saline infusion for labor induction: a randomized controlled trial.

OBJECTIVE: To compare the efficacy of transcervical Foley catheter alone (Foley) to transcervical Foley catheter with extraamniotic saline infusion for labor induction and cervical ripening in women with an unfavorable cervix. METHODS: This was a multicenter, randomized, controlled trial of women presenting for labor induction with a singleton, cephalic fetus, intact membranes, and unfavorable cervix (Bishop score 6 or less). Eligible women were randomly assigned to receive either Foley catheter alone or Foley catheter with extraamniotic saline infusion. All women received concurrent oxytocin administration. The primary study outcome was the induction-to-delivery interval. Secondary outcomes included cesarean delivery, maternal infectious outcomes, and immediate neonatal outcomes. Analysis was by intent to treat. RESULTS: One hundred eighty-eight women met eligibility criteria and were randomly assigned (Foley plus extraamniotic saline infusion, n=97; Foley, n=91). Baseline demographic characteristics, including parity, gestational age, and Bishop score were similar between the study groups. The median induction-to-delivery interval in the extraamniotic saline infusion arm (12.6 hours, interquartile range 9.3-18.8 hours) was similar to that in the Foley arm (13.4 hours, interquartile range 9.6-17.5 hours) (P=. 70). The proportion of women delivered by 24 hours was comparable between groups (delivery 24 hours, extraamniotic saline infusion 89.7%, Foley 87.9%, P=.70), as was the rate of cesarean delivery (Foley 18.7%, extraamniotic saline infusion 27.8%, P=.14). No significant differences were noted between the study groups with respect to rate of chorioamnionitis, endometritis, or immediate birth outcomes. CONCLUSION: In women with an unfavorable cervix, the addition of extraamniotic saline infusion to a transcervical Foley catheter does not improve efficacy for labor induction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00442663 LEVEL OF EVIDENCE: I.

Subcutaneous tissue reapproximation, alone or in combination with drain, in obese women undergoing cesarean delivery.

OBJECTIVE: To compare the efficacy of subcutaneous suture reapproximation alone with suture plus subcutaneous drain for the prevention of wound complications in obese women undergoing cesarean delivery. METHODS: We conducted a multicenter randomized trial of women undergoing cesarean delivery. Consenting women with 4 cm or more of subcutaneous thickness were randomized to either subcutaneous suture closure alone (n = 149) or suture plus drain (n = 131). The drain was attached to bulb suction and removed at 72 hours or earlier if output was less than 30 mL/24 h. The primary study outcome was a composite wound morbidity rate (defined by any of the following: subcutaneous tissue dehiscence, seroma, hematoma, abscess, or fascial dehiscence). RESULTS: From April 2001 to July 2004, a total of 280 women were enrolled. Ninety-five percent of women (268/280) had a follow-up wound assessment. Both groups were similar with respect to age, race, parity, weight, cesarean indication, diabetes, steroid/antibiotic use, chorioamnionitis, and subcutaneous thickness. The composite wound morbidity rate was 17.4% (25/144) in the suture group and 22.7% (28/124) in the suture plus drain group (relative risk 1.3, 95% confidence interval 0.8-2.1). Individual wound complication rates, including subcutaneous dehiscence (15.3% versus 21.8%), seroma (9.0% versus 10.6%), hematoma (2.2% versus 2.4%), abscess (0.7% versus 3.3%), fascial dehiscence (1.4% versus 1.7%), and hospital readmission for wound complications (3.5% versus 6.6%), were similar (P > .05) between women treated with suture alone and those treated with suture plus drain, respectively. CONCLUSION: The additional use of a subcutaneous drain along with a standard subcutaneous suture reapproximation technique is not effective for the prevention of wound complications in obese women undergoing cesarean delivery.

Screening for gestational diabetes mellitus in the subsequent pregnancy: is it worthwhile?

OBJECTIVE: The purpose of this study was to determine, among women without evidence of gestational diabetes mellitus during their first pregnancy, the likelihood of, and associated risk factors for, the development of gestational diabetes mellitus in the subsequent pregnancy. STUDY DESIGN: This was a retrospective cohort study, with a time frame of 1991 to 1999. RESULTS: Of 3710 women without gestational diabetes mellitus in the first pregnancy, 1% (37 women) were subsequently diagnosed with gestational diabetes mellitus in the second pregnancy. These 37 women, when compared (by means) to women without gestational diabetes mellitus in their second pregnancy, were more likely to be older (age 21 years vs 19 years) and obese (first visit body mass index, 28 kg/m(2) vs 25 kg/m(2)) and to have an interpregnancy weight gain of >5 kg (93% vs 49%) and a longer mean interpregnancy interval (33 months vs 24 months). Regression analysis revealed that, during the first pregnancy, a first visit body mass index of >29 kg/m(2) (odds ratio, 2.2; 95% CI, 1.1-4.5) and a serum glucose screen of >101 mg/dL (odds ratio, 8.3; 95% CI, 2.5-27.9) were associated significantly with the development of gestational diabetes mellitus in the second pregnancy, as was an interpregnancy weight gain of >5 kg (odds ratio, 10.8; 95% CI, 2.5-46.3). All women who subsequently had gestational diabetes mellitus had at least one of these risk factors. CONCLUSION: Among women without gestational diabetes mellitus in the first pregnancy, the risk of gestational diabetes mellitus in a second pregnancy is low. Therefore, screening all such women in the second pregnancy may not be justified.