Lisa D. Levine

Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial

OBJECTIVE: To evaluate the effectiveness of four commonly used induction methods. METHODS: This randomized trial compared four induction methods: misoprostol alone, Foley alone, misoprostol–cervical Foley concurrently, and Foley–oxytocin concurrently. Women undergoing labor induction with full-term (37 weeks of gestation or greater), singleton, vertex-presenting gestations, with no contraindication to vaginal delivery, intact membranes, Bishop score 6 or less, and cervical dilation 2 cm or less were included. Women were enrolled only once during the study period. Our primary outcome was time to delivery. Neither patients nor health care providers were blinded to assigned treatment group because examinations are required for placement of all methods; however, research personnel were blinded during data abstraction. A sample size of 123 per group (n=492) was planned to compare the four groups pairwise (P⩽.008) with a 4-hour reduction in delivery time considered clinically meaningful. RESULTS: From May 2013 through June 2015, 997 women were screened and 491 were randomized and analyzed. Demographic and clinical characteristics were similar among the four treatment groups. When comparing all induction method groups, combination methods achieved a faster median time to delivery than single-agent methods (misoprostol–Foley: 13.1 hours, Foley–oxytocin: 14.5 hours, misoprostol: 17.6 hours, Foley: 17.7 hours, P<.001). When censored for cesarean delivery and adjusting for parity, women who received misoprostol–Foley were almost twice as likely to deliver before women who received misoprostol alone (hazard ratio 1.92, 95% confidence interval [CI] 1.42–2.59) or Foley alone (hazard ratio 1.87, 95% CI 1.87 1.39–2.52), whereas Foley–oxytocin was not statistically different from single-agent methods. CONCLUSION: After censoring for cesarean delivery and adjusting for parity, misoprostol–cervical Foley resulted in twice the chance of delivering before either single-agent method. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01916681.

Excessive weight gain and hypertensive disorders of pregnancy in the obese patient.

Abstract Objective: To evaluate the association between excessive weight gain and pregnancy-related hypertension (PRH) among obese women (body mass index (BMI) ≥30 kg/m2). Methods: We performed a case control study among women with (n = 440) and without (n = 600) PRH from 2005 to 2007. Height and weight were recorded at initial and final prenatal visits. 695 women had BMI recorded at ≤18 weeks of gestation, of which 257 (36.9%) were obese. Obese women were divided into three categories based on 2009 Institute of Medicine (IOM) guidelines: (1) below recommended amount (under weight gain – UWG); (2) more than recommended (excessive weight gain – EWG) or (3) within recommended amount (normal weight gain – NWG). PRH was defined as gestational hypertension, mild or severe preeclampsia. Patients with and without PRH were prospectively identified. The association between weight gain category and development of PRH was analyzed. Results: We noticed a 1.5-fold higher odds of having PRH with an initial BMI ≥30 kg/m2 compared to BMI <30 kg/m2 (OR 1.64, 95% CI 1.2–2.2, p = 0.002). Among obese women, we noted a 2-fold higher odds of having PRH with EWG compared to NWG (OR 2.52, 95% CI 1.2–3.9, p = 0.012). The increased odds persisted after adjusting for race, chronic hypertension and diabetes, and length of gestation (AOR 2.61, 95% CI 1.4–4.9, p = 0.003). Among obese women with PRH, those with EWG had a 76% decreased odds of having severe disease compared to NWG (OR = 0.242 [0.07–0.79], p = 0.019). Conclusion: We have demonstrated that EWG among obese patients increases overall risk of PRH.

Patient characteristics associated with 17-alpha hydroxyprogesterone caproate use among a high-risk cohort

BACKGROUND Preterm birth (PTB) remains a significant cause of neonatal morbidity and mortality. Women with a prior PTB are at risk for recurrent PTB. Treatment with 17-alpha hydroxyprogesterone caproate (17OHP-C) has become standard of care for women with prior PTB to help reduce this risk. Factors that affect a womans decision to use this medication are largely unknown. OBJECTIVE The objective of our study was to investigate patient-level barriers to 17OHP-C. We studied a cohort of women eligible for 17OHP-C with the hypothesis that 17OHP-C is underutilized and certain patient characteristics, such as obstetrical history, influence its use. STUDY DESIGN A cross-sectional study of all women seen at a specialty prematurity clinic from 2009 through 2013 was performed. Women with a singleton pregnancy were included if they had a prior spontaneous PTB (sPTB). The χ(2) tests were performed for univariate analyses. Multivariable logistic regression was used to control for confounders. RESULTS In all, 243 women had 17OHP-C recommended to them based on obstetrical history. There were 218 women with a pregnancy during our study period that were included in our analysis. A total of 163 (74.7%) had documented 17OHP-C use. Women were more likely to accept 17OHP-C if they had a history of a second-trimester loss only (odds ratio [OR], 2.32; 95% confidence interval [CI], 1.17-4.58) or received recommendation for cerclage due to a short cervical length (OR, 4.12; 95% CI, 1.55-10.99). Women with a prior full-term birth were less likely to accept 17OHP-C (OR, 0.48; 95% CI, 0.26-0.89), especially when the prior full-term birth was subsequent rather than prior to the PTB (OR, 0.19; 95% CI, 0.08-0.47). Race, obesity, and insurance status did not impact 17OHP-C use. There was no difference in the rate of sPTB between those who used and did not use 17OHP-C (37.2 vs 34.0%, P = .7). CONCLUSION Obstetric history impacted 17OHP-C use. This study identifies biases regarding 17OHP-C at the patient level and can be used to develop strategies to increase its use. However, the similarity in the sPTB rate between users and nonusers highlights the importance of identifying specific populations where 17OHP-C is and is not effective in preventing PTB.

Term induction of labor and risk of cesarean delivery by parity

Abstract Objective: To evaluate the risk of cesarean delivery among both nulliparous and multiparous women undergoing a term induction of labor compared to women that present in spontaneous labor at term. Methods: We performed a retrospective cohort study of term (≥37 weeks) singleton pregnancies between 2005 and 2010 comparing women that had an induction to those that presented in spontaneous labor. Multiparity was defined as a prior delivery after 20 weeks’ gestation. Chi-square was used to compare categorical variables. Multivariable logistic regression was used to control for confounders. Analyses were stratified by parity. Results: 863 women were included in the analysis. There were 605 inductions (cesarean rate 23%) and 257 spontaneous labor (cesarean rate 7%), OR 3.4, 95% CI [2.1–5.4]. Stratified by parity, nulliparas undergoing induction had an increased cesarean rate compared to spontaneous labor (27% versus 11%, OR 3.13, 95% CI [1.76–5.57]) as did multiparas (13% versus 3%, OR 4.04, 95% CI [1.36–11.94]). This increased risk for cesarean after induction remained in both nulliparous and multiparous women even after controlling for confounders (aOR 2.90, 95% CI [1.60–5.25] and aOR 3.47, 95% CI [1.12–10.67], respectively). Neither starting cervical exam nor indication for induction altered this increased risk. Conclusions: The increased risk of cesarean in women undergoing an induction is present regardless of parity and indication for induction. This should be taken into account when counseling women regarding risks of induction, regardless of parity. Future studies should focus on other clinical characteristics of induction that may mitigate this risk.

Comparison of Clinical Characteristics and Outcomes of Peripartum Cardiomyopathy Between African American and Non–African American Women

Importance Peripartum cardiomyopathy (PPCM) disproportionately affects women of African ancestry, but well-powered studies to explore differences in severity of disease and clinical outcomes are lacking. Objective To compare the clinical characteristics, presentation, and outcomes of PPCM between African American and non–African American women. Design, Setting, and Participants This retrospective cohort study using data from January 1, 1986, through December 31, 2016, performed at the University of Pennsylvania Health System, a tertiary referral center serving a population with a high proportion of African American individuals, included 220 women with PPCM. Main Outcomes and Measures Demographic and clinical characteristics and echocardiographic findings at presentation, as well as clinical outcomes including cardiac recovery, time to recovery, cardiac transplant, persistent dysfunction, and death, were compared between African American and non–African American women with PPCM. Results A total of 220 women were studied (mean [SD] age at diagnosis, 29.5 [6.6] years). African American women were diagnosed with PPCM at a younger age (27.6 vs 31.7 years, P < .001), were diagnosed with PPCM later in the postpartum period, and were more likely to present with a left ventricular ejection fraction less than 30% compared with non–African American women (48 [56.5%] vs 30 [39.5%], P = .03). African American women were also more likely to worsen after initial diagnosis (30 [35.3%] vs 14 [18.4%], P = .02), were twice as likely to fail to recover (52 [43.0%] vs 24 [24.2%], P = .004), and, when they did recover, recovery took at least twice as long (median, 265 vs 125.5 days; P = .02) despite apparent adequate treatment. Conclusions and Relevance In a large cohort of women with well-phenotyped PPCM, this study demonstrates a different profile of disease in African American vs non–African American women. Further work is needed to understand to what extent these differences stem from genetic or socioeconomic differences and how treatment of African American patients might be tailored to improve health outcomes.

Is obesity an independent barrier to obtaining prenatal care

OBJECTIVE Obesity is a demonstrated barrier to obtaining health care. Its impact on obtaining prenatal care (PNC) is unknown. Our objective was to determine if obesity is an independent barrier to accessing early and adequate PNC. STUDY DESIGN We performed a retrospective cohort study of women who initiated PNC and delivered at our institution in 2005. Body mass index (BMI) was categorized by World Health Organization guidelines: underweight (<18.5 kg/m(2)), normal weight (18.5 to 24.9 kg/m(2)), overweight (25.0 to 29.9 kg/m(2)), and obese (≥30 kg/m(2)). Maternal history and delivery information were obtained through chart abstraction. Differences in gestational age at first visit (GA-1) and adequate PNC were evaluated by BMI category. Data were compared using χ(2) and nonparametric analyses. RESULTS Overall, 410 women were evaluated. The median GA-1 was 11.1 weeks and 69% had adequate PNC. There was no difference in GA-1 or adequate PNC by BMI category (p = 0.17 and p = 0.66, respectively). When BMI groups were dichotomized into obese and nonobese women, there was no difference in GA-1 or adequate PNC (p = 0.41). CONCLUSION In our population, obesity is not an independent barrier to receiving early and adequate PNC. Future work is warranted in evaluating the association between obesity and PNC and the perceived barriers to obtaining care.

A 5-day educational program for teaching cervical cancer screening using visual inspection with acetic acid in low-resource settings

To assess the effectiveness of an educational program in visual inspection with acetic acid (VIA) for cervical cancer screening among healthcare providers in 2 low‐resource countries.

Factors associated with postpartum follow-up and persistent hypertension among women with severe preeclampsia

Objective:To determine factors associated with lower 6-week postpartum follow-up rates and persistent hypertension among women with preeclampsia with severe features (PEC-S).Study Design:Planned secondary analysis of a retrospective cohort study of women with PEC-S. Outcomes were (1) attendance at the 6-week postpartum visit and (2) persistent hypertension.Results:One hundred ninety-three women were in the final cohort. The 6-week follow-up rate was 52.3%. Factors associated with lower follow-up were African-American race (OR 0.37 (0.18–0.77)) and <5 prenatal visits (OR 0.44 (0.20–0.97)). Women with diabetes and women with a cesarean had higher follow-up (OR 4.00 (1.09–14.66) and 2.61 (1.40–4.88), respectively). Among those with 6-week follow-up, 21% had persistent hypertension. Obese women, women diagnosed with PEC-S by severe range blood pressure (BP) and women discharged home on BP medication were more likely to have persistent hypertension (OR 3.50 7 (1.06–11.58), 3.58 (1.11-11.54) and 3.04 (1.12–8.23), respectively).Conclusion:We identified a subgroup of women at higher risk for poor postpartum follow-up and those at risk for persistent hypertension.

Enhanced physician prompts in prenatal electronic medical records impact documentation on smoking cessation.

Objective Smoking cessation during pregnancy is a modifiable intervention that can improve maternal and neonatal outcomes. Encouraging smoking cessation is an assessed measure of the Meaningful Use incentives to ensure best practices with the increased use of the electronic medical record (EMR). Physician EMR prompts have been used shown to be successful with preventive care but there is a paucity of data evaluating prompts within obstetrics. The objective of this study is to determine the effectiveness of enhanced smoking cessation prompts in a prenatal EMR. Methods A retrospective cohort study of an enhanced smoking cessation prompting system within our prenatal EMR was performed. Pregnant women who reported tobacco use at first prenatal visit were included. The number of times a smoking cessation method was offered and documented, the number of documented attempts at smoking cessation, and the final number of cigarettes smoked were compared pre and post the enhancement of the smoking cessation prompting system. Results 95 patients were included (48 pre-enhancement; 47 post-enhancement). Post-enhancement, the documentation of smoking cessation method offered increased (0 vs. 1, p = 0.03) and documentation of smoking cessation attempts increased (1 vs. 2, p = 0.006). There was no change in the final number of cigarettes smoked (p = 0.9). Conclusions Enhanced prompting systems increase documentation related to smoking cessation with no change in number of cigarettes smoked. In the era of Meaningful Use guidelines which focus on documentation in the EMR, continued research must be done to assure that software enhancements and improved documentation truly result in improved patient care.

Length of second stage of labor and preterm birth in a subsequent pregnancy

BACKGROUND During the second stage of labor, it is plausible that the pressure of the fetal head against a completely dilated cervix may lead to changes in the cervical integrity and cervical strength lending it susceptible to premature dilation in a subsequent pregnancy. Therefore, a prolonged second stage of labor has been hypothesized to be a risk factor for cervical insufficiency and spontaneous preterm birth (sPTB). OBJECTIVE We sought to evaluate the effect that the length of second stage of labor in one pregnancy has on the risk of sPTB in a subsequent pregnancy. STUDY DESIGN This was a planned secondary analysis of a large retrospective cohort study of women with 2 consecutive deliveries at our institution from 2005 through 2010. Women with a term pregnancy that reached the second stage were included; women with a prior sPTB were excluded. The primary outcome was sPTB <37 weeks. A prolonged second stage was defined as ≥3 hours. Fisher exact tests were used to compare categorical data. Linear and logistic regression was used to calculate odds. RESULTS In all, 757 women were included. The overall length of the second stage ranged from 0-7.3 hours. The sPTB rate in a subsequent pregnancy was 8.7%. There was no association between length of second stage (hours) as a continuous variable and sPTB after adjusting for confounders (adjusted odds ratio, 0.83; [95% CI 0.58-1.20]). A prolonged second stage ≥3 hours occurred in 48 (6.3%) women. Women with a second stage ≥3 hours were older, less likely to be African American, and were less likely to be overweight or obese as compared to women with a second stage <3 hours. The women with second stage ≥3 hours were more likely to be nulliparous and have a larger neonate. The sPTB risk was not different between a second stage ≥3 hours (10.4%) and <3 hours (7.9%), P = .5. The sPTB risk was, however, modified by mode of delivery in the second stage. There was no difference in sPTB rate among women with a vaginal delivery when comparing those with and without a prolonged second stage (7.4 vs 7.8%, P = .9). There also was no difference among women with a cesarean when comparing those with and without a prolonged second stage (11.8 vs 14.3%, P = .8). While not statistically significant, the absolute risk of a subsequent sPTB after a cesarean delivery with a second stage ≥3 hours is twice as high as the risk of a sPTB after a vaginal delivery with a second stage ≥3 hours (adjusted odds ratio, 2.08; [0.32-13.78]). CONCLUSION A prolonged second stage of labor alone does not increase the risk of sPTB in a subsequent pregnancy. Cesarean delivery after a prolonged second stage of labor may confer a possible increased risk. It is important to continue to evaluate potential risk factors for sPTB. If these risk factors are confirmed in future studies, it will aid in the counseling of women and may open the door for therapeutic strategies to be studied among these newly identified at-risk women.