Wilson Huang

A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction.

OBJECTIVE The purpose of this study was to determine the efficacy of combination intravaginal misoprostol and intracervical Foley catheter for prelabor cervical ripening. STUDY DESIGN A prospective, randomized controlled trial was conducted. Women who were undergoing labor induction, with a singleton gestation >or=28 weeks and an unfavorable cervix (Bishop score <or=6), were assigned to one of three groups: (1) intravaginal misoprostol 25 mug every 3 hours, (2) intracervical 16F Foley catheter, or (3) combination misoprostol-Foley catheter. RESULTS Among 146 patients, 49 patients were assigned to misoprostol, 54 patients were assigned to Foley catheter, and 43 patients were assigned to combination therapy. There was no difference in vaginal delivery rates (misoprostol, 63.3%; Foley, 57.4%; combination, 58.1%; P=.81). There were also no statistically significant differences in the interval between induction to active phase, active phase to delivery, or induction to delivery among the three groups. CONCLUSION Intravaginal misoprostol and intracervical Foley catheter are comparable for preinduction cervical ripening. The combination of the two methods did not provide additional efficacy.

Implementation of a laborist program and evaluation of the effect upon cesarean delivery

OBJECTIVE Laborist programs have expanded throughout the United States in the last decade. Meanwhile, there has been no published research examining their effect on patient outcomes. Cesarean delivery is a key performance metric with maternal health implications and significant financial impact. Our hypothesis is that the initiation of a full-time dedicated laborist staff decreases cesarean delivery. STUDY DESIGN In a tertiary hospital staffed with private practice physicians, data were retrospectively reviewed for 3 time periods from 2006 through 2011. The first period (16 months) there were no laborists (traditional model), followed by 14 months of continuous in-hospital laborist coverage provided by community staff (community laborist), and finally a 24-month period with full-time laborists providing continuous in-hospital coverage. The primary hypothesis was that full-time laborists would decrease cesarean delivery rates. RESULTS Data from 6206 term nulliparous patients were retrospectively reviewed. The cesarean delivery rate for no laborist care was 39.2%, for community physician laborist care was 38.7%, and for full-time laborists was 33.2%. With adjustment via logistic regression, full-time laborist presence was associated with a significant reduction in cesarean delivery when contrasted with no laborist (odds ratio, 0.73; 95% confidence interval, 0.64-0.83; P < .0001) or community laborist care (odds ratio, 0.77; 95% confidence interval, 0.67-0.87; P < .001). The community laborist model was not associated with an effect upon cesarean delivery. CONCLUSION A dedicated full-time laborist staff model is associated with lower rates of cesarean delivery. These findings may be used as part of a strategy to reduce cesarean delivery, lower maternal morbidity and mortality, and decrease health care costs.

17-hydroxyprogesterone caproate for preterm rupture of the membranes: a multicenter, randomized, double-blind, placebo-controlled trial.

OBJECTIVE Preterm rupture of membranes (PROM) is associated with an increased risk of preterm birth and neonatal morbidity. Prophylactic 17-hydroxyprogesterone caproate (17OHP-C) reduces the risk of preterm birth in some women who are at risk for preterm birth. We sought to test whether 17OHP-C would prolong pregnancy or improve perinatal outcome when given to mothers with preterm rupture of the membranes. STUDY DESIGN This is a multicenter, double-blind, placebo-controlled, randomized clinical trial. The study included singleton pregnancies with gestational ages from 23(0/7) to 30(6/7) weeks at enrollment, documented PROM, and no contraindication to expectant management. Consenting women were assigned randomly to receive weekly intramuscular injections of 17OHP-C (250 mg) or placebo. The primary outcome was continuation of pregnancy until a favorable gestational age, which was defined as either 34(0/7) weeks of gestation or documentation of fetal lung maturity at 32(0/7) to 33(6/7) weeks of gestation. The 2 prespecified secondary outcomes were interval from randomization to delivery and composite adverse perinatal outcome. The planned sample size was 222 total women. RESULTS From October 2011 to April 2014, 152 women were enrolled; 74 women were allocated randomly to 17OHP-C, and 78 were allocated randomly to placebo. The trial was stopped when results of a planned interim analysis suggested that continuation was futile. The primary outcome was achieved in 3% of the 17OHP-C group and 8% of the placebo group (P = .18). There was no significant between-group difference in the prespecified secondary outcomes, randomization-to-delivery interval (17.1 ± 16.1 vs 17.0 ± 15.8 days, respectively; P = .76) or composite adverse perinatal outcome (63% vs 61%, respectively; P = .93). No significant differences were found in other outcomes, which included rates of chorioamnionitis, postpartum endometritis, cesarean delivery, individual components of the composite outcome, or prolonged neonatal length of stay. CONCLUSION Compared with placebo, weekly 17OHP-C injections did not prolong pregnancy or reduce perinatal morbidity in patients with PROM in this trial.

17-hydroxyprogesterone caproate for preterm rupture of the membranes

OBJECTIVE Preterm rupture of membranes (PROM) is associated with an increased risk of preterm birth and neonatal morbidity. Prophylactic 17-hydroxyprogesterone caproate (17OHP-C) reduces the risk of preterm birth in some women who are at risk for preterm birth. We sought to test whether 17OHP-C would prolong pregnancy or improve perinatal outcome when given to mothers with preterm rupture of the membranes. STUDY DESIGN This is a multicenter, double-blind, placebo-controlled, randomized clinical trial. The study included singleton pregnancies with gestational ages from 23(0/7) to 30(6/7) weeks at enrollment, documented PROM, and no contraindication to expectant management. Consenting women were assigned randomly to receive weekly intramuscular injections of 17OHP-C (250 mg) or placebo. The primary outcome was continuation of pregnancy until a favorable gestational age, which was defined as either 34(0/7) weeks of gestation or documentation of fetal lung maturity at 32(0/7) to 33(6/7) weeks of gestation. The 2 prespecified secondary outcomes were interval from randomization to delivery and composite adverse perinatal outcome. The planned sample size was 222 total women. RESULTS From October 2011 to April 2014, 152 women were enrolled; 74 women were allocated randomly to 17OHP-C, and 78 were allocated randomly to placebo. The trial was stopped when results of a planned interim analysis suggested that continuation was futile. The primary outcome was achieved in 3% of the 17OHP-C group and 8% of the placebo group (P = .18). There was no significant between-group difference in the prespecified secondary outcomes, randomization-to-delivery interval (17.1 ± 16.1 vs 17.0 ± 15.8 days, respectively; P = .76) or composite adverse perinatal outcome (63% vs 61%, respectively; P = .93). No significant differences were found in other outcomes, which included rates of chorioamnionitis, postpartum endometritis, cesarean delivery, individual components of the composite outcome, or prolonged neonatal length of stay. CONCLUSION Compared with placebo, weekly 17OHP-C injections did not prolong pregnancy or reduce perinatal morbidity in patients with PROM in this trial.

17-hydroxyprogesterone caproate for preterm rupture of the membranes: A multicenter, randomized, double-blind, placebo-controlled trial Presented in poster format at the 35th annual meeting of the Society for Maternal-Fetal Medicine, San Diego, CA, Feb. 2-7, 2015.

OBJECTIVE Preterm rupture of membranes (PROM) is associated with an increased risk of preterm birth and neonatal morbidity. Prophylactic 17-hydroxyprogesterone caproate (17OHP-C) reduces the risk of preterm birth in some women who are at risk for preterm birth. We sought to test whether 17OHP-C would prolong pregnancy or improve perinatal outcome when given to mothers with preterm rupture of the membranes. STUDY DESIGN This is a multicenter, double-blind, placebo-controlled, randomized clinical trial. The study included singleton pregnancies with gestational ages from 23(0/7) to 30(6/7) weeks at enrollment, documented PROM, and no contraindication to expectant management. Consenting women were assigned randomly to receive weekly intramuscular injections of 17OHP-C (250 mg) or placebo. The primary outcome was continuation of pregnancy until a favorable gestational age, which was defined as either 34(0/7) weeks of gestation or documentation of fetal lung maturity at 32(0/7) to 33(6/7) weeks of gestation. The 2 prespecified secondary outcomes were interval from randomization to delivery and composite adverse perinatal outcome. The planned sample size was 222 total women. RESULTS From October 2011 to April 2014, 152 women were enrolled; 74 women were allocated randomly to 17OHP-C, and 78 were allocated randomly to placebo. The trial was stopped when results of a planned interim analysis suggested that continuation was futile. The primary outcome was achieved in 3% of the 17OHP-C group and 8% of the placebo group (P = .18). There was no significant between-group difference in the prespecified secondary outcomes, randomization-to-delivery interval (17.1 ± 16.1 vs 17.0 ± 15.8 days, respectively; P = .76) or composite adverse perinatal outcome (63% vs 61%, respectively; P = .93). No significant differences were found in other outcomes, which included rates of chorioamnionitis, postpartum endometritis, cesarean delivery, individual components of the composite outcome, or prolonged neonatal length of stay. CONCLUSION Compared with placebo, weekly 17OHP-C injections did not prolong pregnancy or reduce perinatal morbidity in patients with PROM in this trial.