Noah Zafran

Single-balloon compared with double-balloon catheters for induction of labor: a randomized controlled trial.

OBJECTIVE: To estimate the efficacy of a single-balloon catheter compared with a double-balloon catheter among women with unfavorable cervices undergoing induction of labor. METHODS: This prospective randomized study was conducted at a university teaching medical center between June 2008 and December 2010. Pregnant women admitted for induction of labor with a live singleton gestation in cephalic presentation with intact membranes and a Bishop score of 6 or less were randomly assigned for cervical ripening by a single-balloon catheter or a double-balloon catheter. The primary outcome was the length of time from catheter insertion until delivery. The secondary outcome was mode of delivery. RESULTS: Of 368 eligible women screened during the study period, 293 were included in the final analysis; 145 were randomly assigned to receive a single-balloon catheter and 148 received a double-balloon catheter. Demographic and obstetric parameters were comparable between the two groups. Length of time from catheter insertion until delivery was 19.4 (±6.0) and 19.1 (±6.8) hours among the single-balloon and the double-balloon catheter groups, respectively (P=.80). Length of time did not differ when primiparous women were analyzed separately. Incidence of cesarean delivery was 10.3% and 17.6% among the single-balloon and double-balloon catheter groups, respectively (P=.09). The incidence of either vacuum deliveries or cesarean deliveries was significantly lower among the single-balloon group (14.4%) compared with the double-balloon catheter group (25.7%; odds ratio 0.49, 95% confidence interval 0.26–0.92; P=.02). CONCLUSION: Both the single-balloon and double-balloon catheters are equally efficacious for inducing labor. The double-balloon catheter may be associated with more operative deliveries. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00690040. LEVEL OF EVIDENCE: I

Comparison between amniotomy, oxytocin or both for augmentation of labor in prolonged latent phase: a randomized controlled trial

BackgroundA prolonged latent phase is independently associated with an increased incidence of subsequent labor abnormalities. We aimed to compare between oxytocin augmentation, amniotomy and a combination of both on the duration of labor among women with a prolonged latent phase.MethodsWomen with a singleton fetus in cephalic presentation who have a prolonged latent phase, were randomly allocated to amniotomy (group 1), oxytocin (group 2) or both (group 3). A group of women who progressed spontaneously without intervention composed the control group (group 4). The primary outcome was the duration of time from initiation of augmentation until delivery.ResultsA total of 213 women were consented and randomized to group 1 (70 women), group 2 (72 women) and group 3 (71 women). Group 4 was composed from additional 70 women. A mean reduction of 120 minutes in labor duration was observed among group 3 compared to group 1 (p = 0.08) and 180 minutes compared to group 2 and 4 (p = 0.001). Women in group 3 had a shorter length of time from augmentation until the beginning of the active phase and a shorter first stage of labor than group 1 (p = 0.03), group 2 (p = 0.001) and group 4 (p = 0.001). Satisfaction was greater among group 3 and 4. Mode of delivery and neonatal outcome were comparable between the groups.ConclusionLabor augmentation by combined amniotomy and oxytocin among women with a prolonged latent phase at term seems superior compared to either of them alone.

Nifedipine compared with atosiban for treating preterm labor: a randomized controlled trial.

OBJECTIVE: To compare the tocolytic efficacy and tolerability of nifedipine with that of atosiban among pregnant women with preterm labor. METHODS: Pregnant women admitted with preterm labor and intact membranes between 24 and 33 weeks 6 days of gestation, between January 2008 and December 2011, were randomly assigned to either atosiban or nifedipine treatment. Assigned treatment was planned for up to 48 hours. If progress was determined after 1 hour or more, a crossover of the study drugs was performed. The primary outcome was to estimate the tocolytic efficacy and tolerability profile that was assessed in terms of the proportion of women who were not delivered and did not require an alternate tocolytic agent within 48 hours. Secondary outcomes were gestational age at delivery and neonatal morbidity. RESULTS: Seventy-five women in the nifedipine group and 70 in the atosiban group were included and analyzed. Baseline demographic and obstetric characteristics were comparable. Forty-eight (68.6%) women allocated to atosiban and 39 (52%) to nifedipine did not deliver and did not require an alternate agent at 48 hours respectively (P=.03). At 7 days from enrollment, 55 (78.6%) women allocated to atosiban and 67 (89.3%) to nifedipine remained undelivered with or without a rescue agent (P=.02). Mean gestational age at delivery was 35.2 (±3.0) and 36.4 (±2.8) weeks among the atosiban and nifedipine groups, respectively (P=.01). Mean birth weight and neonatal morbidity were comparable. CONCLUSIONS: Atosiban has fewer failures within 48 hours. Nifedipine may be associated with a longer postponement of delivery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00599898. LEVEL OF EVIDENCE: I

Glyburide Versus Metformin and Their Combination for the Treatment of Gestational Diabetes Mellitus: A Randomized Controlled Study

OBJECTIVE To compare the efficacy and safety of glyburide versus metformin and their combination for the treatment of gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS In this prospective randomized controlled study, we randomly assigned patients with GDM at 13–33 weeks gestation and whose blood glucose was poorly controlled by diet to receive either glyburide or metformin. If optimal glycemic control was not achieved, the other drug was added. If adverse effects occurred, the drug was replaced. If both failed, insulin was given. The primary outcomes were the rate of treatment failure and glycemic control after the first-line medication according to mean daily glucose charts. RESULTS Glyburide was started in 53 patients and metformin in 51. In the glyburide group, the drug failed in 18 (34%) patients due to adverse effects (hypoglycemia) in 6 (11%) and lack of glycemic control in 12 (23%). In the metformin group, the drug failed in 15 (29%) patients, due to adverse effects (gastrointestinal) in 1 (2%) and lack of glycemic control in 14 (28%). Treatment success after second-line therapy was higher in the metformin group than in the glyburide group (13 of 15 [87%] vs. 9 of 18 [50%], respectively; P = 0.03). In the glyburide group, nine (17%) patients were eventually treated with insulin compared with two (4%) in the metformin group (P = 0.03). The combination of the drugs reduced the need for insulin from 33 (32%) to 11 (11%) patients (P = 0.0002). Mean daily blood glucose and other obstetrical and neonatal outcomes were comparable between groups, including macrosomia, neonatal hypoglycemia, and electrolyte imbalance. CONCLUSIONS Glyburide and metformin are comparable oral treatments for GDM regarding glucose control and adverse effects. Their combination demonstrates a high efficacy rate with a significantly reduced need for insulin, with a possible advantage for metformin over glyburide as first-line therapy.

Postcesarean wound infection: prevalence, impact, prevention, and management challenges

Surgical site infection (SSI) is one of the most common complications following cesarean section, and has an incidence of 3%–15%. It places physical and emotional burdens on the mother herself and a significant financial burden on the health care system. Moreover, SSI is associated with a maternal mortality rate of up to 3%. With the global increase in cesarean section rate, it is expected that the occurrence of SSI will increase in parallel, hence its clinical significance. Given its substantial implications, recognizing the consequences and developing strategies to diagnose, prevent, and treat SSI are essential for reducing postcesarean morbidity and mortality. Optimization of maternal comorbidities, appropriate antibiotic prophylaxis, and evidence-based surgical techniques are some of the practices proven to be effective in reducing the incidence of SSI. In this review, we describe the biological mechanism of SSI and risk factors for its occurrence and summarize recent key clinical trials investigating preoperative, intraoperative, and postoperative practices to reduce SSI incidence. It is prudent that the surgical team who perform cesarean sections be familiar with these practices and apply them as needed to minimize maternal morbidity and mortality related to SSI.

Timing of elective repeat cesarean delivery at term.

To the Editor: Tita et al. (Jan. 8 issue) suggest that delaying elective repeat cesarean delivery until 39 weeks of gestation will decrease the incidence of neonatal morbidity.1 However, delaying repeat cesarean delivery may have maternal and fetal consequences that are not addressed in their report. Between 38 and 39 weeks of gestation, approximately 10% of women go into spontaneous labor,2 with the result that planned cesarean deliveries are converted to emergency ones. The incidence of severe maternal morbidity is significantly higher among women undergoing emergency cesarean delivery than among those undergoing elective cesarean delivery.3 Complications may be greater among women after higher-order repeat cesarean deliveries4 and among older women.5 Therefore, the benefits of reducing neonatal morbidity from 11% at 38 weeks to 8% at 39 weeks, as reported by Tita et al., need to be weighed against the possible increase in the risks of severe maternal morbidity and perinatal mortality associated with delaying delivery. Raed Salim, M.D. Noah Zafran, M.D. Eliezer Shalev, M.D.

Employing nifedipine as a tocolytic agent prior to external cephalic version

Background. External cephalic version (ECV) is accepted as a means of reducing the rate of breech presentation at term. Routine use of tocolysis prior to an ECV has been described to increase its success rate. The studys objective was to evaluate the efficacy of oral nifedipine as a tocolytic agent prior to ECV, and to compare it with intravenous ritodrine (IR). Methods. Women with breech presentation at term considered suitable for ECV were given nifedipine prior to the procedure. The success rate was compared to a cohort of women who underwent an ECV attempt at our department during the years 1999–2002 using IR prior to the procedure. Power analysis indicated that 70 women were needed in each group to detect a difference of 25% from our baseline success rate of 50%. Results. Seventy‐six women receiving nifedipine before their ECV attempt were compared to 90 women who received IR. Age, parity, gestational age at ECV, type of breech, placental location, fetal weight, and gestational age at delivery were not different between the groups. The overall success rate was 54% and 50% in the nifedipine and ritodrine groups respectively (p = 0.6). The success rate among primiparous women was 35% and 29% respectively (p = 0.8). The success rate among multiparous women was 64% and 63% respectively (p = 1.0). The success rate was statistically different between primiparous and multiparous women in each group (p<0.05). Conclusion. Oral nifedipine may be as effective as IR when administered before ECV.

Are there modifiable risk factors that may predict the occurrence of brachial plexus injury

Objective:To identify risk factors, particularly modifiable, associated with brachial plexus injury.Study Design:A retrospective case–control study conducted at a single hospital between the years 1993 and 2012. All neonates who were diagnosed of brachial plexus injury were included. A control group matched at a ratio of 1:2 was randomly selected. Demographic and obstetric data were obtained from the hospital discharge register with ICD-9 codes and crosschecked with the labor medical records. All medical files were manually checked and validated. A stepwise logistic regression model was performed to identify independent predictors for brachial plexus injury before delivery among those found significant in the univariate analysis.Results:Of all 83 806 deliveries that took place during this period, 144 cases of brachial plexus injury were identified (1.7/1000 deliveries). Overall, 142 cases and 286 controls had available data. Among the study group, 41 (28.9%) had documented shoulder dystocia compared with 1 (0.4%) among the controls (P<0.0001). Logistic regression analysis revealed that maternal age above 35 years (P=0.01; odds ratio (OR) 2.7; 95% confidence interval (CI) 1.3 to 5.7), estimated fetal weight before delivery (P<0.0001; OR 2.5; 95% CI 1.7 to 3.8, for each 500 g increase), vaginal birth after cesarean (P=0.02; OR 3.3; 95% CI 1.2 to 8.8) and vacuum extraction (P=0.02; OR 3.6; 95% CI 1.2 to 10.3) were all found to be independent predictors for developing brachial plexus injury. When stratifying the analysis according to parity, vacuum delivery was found to be an independent risk factor only among primiparous women (OR 6.0; 95% CI 1.7 to 21.6).Conclusions:The findings suggest that very few factors contributing to brachial plexus injury are modifiable. For that reason, it remains an unpredictable and probably an unavoidable event.

Correlation between Clinical, Placental Histology and Microbiological Findings in Spontaneous Preterm Births

Aims: To examine the occurrence of chorioamnionitis and abruption among women who had a spontaneous preterm birth (SPTB), the correlation between clinical and placental findings, and the impact of these complications on neonatal outcome after delivery. Methods: This was a retrospective case-control study conducted between 2008 and 2012 at a single teaching hospital. The study group included all women who had an SPTB (23-36 weeks). Placentas were cultured and underwent histological examination. Results: A total of 478 women were included. The mean gestational age at delivery was 32.6 ± 3.1 weeks. Overall, 260 (54.4%) women had either clinical and/or histological abruption or chorioamnionitis. Clinical chorioamnionitis was diagnosed before birth in 14 (2.9%) women, while histological chorioamnionitis (HCA) in 84 (17.4%). Overall, 38 neonates had infection. Placental cultures were negative in 65.8% (25/38) of these neonates, and in 77.1% (27/38), HCA was ruled out. Logistic regression analysis revealed that neonatal morbidity and mortality were correlated with gestational age at delivery (p = 0.02), not with placental pathology (p = 0.08). Conclusions: Half of the women with PTB had clinical or histological abruption, chorioamnionitis or both. A partial correlation was found between clinical and placental findings. The main determinant of neonatal outcome was gestational age at delivery and not placental findings.

Comparison of single- and double-balloon catheters for labor induction: a systematic review and meta-analysis of randomized controlled trials

ObjectiveThere is a paucity of head-to-head randomized trials that compare single- and double-balloon catheters, and the results of the available data in terms of time from catheter insertion to delivery and delivery mode are mixed. This meta-analysis of randomized controlled trials compares the efficacy of single- and double-balloon catheters in women undergoing labor induction.Study designSearches were made in MEDLINE, EMBASE, PubMed, ClinicalTrials.gov, and the Cochrane Library from inception through June 2016. Peer-reviewed randomized and quasi-randomized trials that compared single- and double-balloon catheters head-to-head for cervical ripening or labor induction were identified. Eligible study populations consisted of women with singleton pregnancies that had any indication for labor induction and were randomly assigned to undergo induction with a single- or a double-balloon catheter. The primary outcome was time from catheter insertion to delivery and delivery mode. The secondary outcomes were intrapartum fever or chorioamnionitis, woman’s satisfaction, and neonatal Apgar score.ResultsOf the 520 records identified, five randomized trials (996 women; 491 with single-balloon and 505 with double-balloon catheters) were considered eligible and included in the meta-analysis. Time from catheter insertion to delivery did not differ between the two types of catheter (p = 0.527; WMD −0.87; 95% CI: −3.55, 1.82). The incidence of cesarean delivery also did not differ (p = 0.844; RR 0.97; 95% CI: 0.69, 1.35). Delivery within 24 h, delivery mode, incidences of intrapartum fever or chorioamnionitis, and neonatal Apgar score <7 at 5 min did not differ between the two types of catheter as well. Women who were induced with the single-balloon catheter were more satisfied (p = 0.029; WMD 0.56; 95% CI: 0.06, 1.06).ConclusionTime from catheter insertion to delivery and delivery mode were comparable between the two types of catheter.