Katheryne L. Downes

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.

Neonatal Outcomes Associated With Placental Abruption

Placental abruption (early separation of the placenta) is associated with preterm birth and perinatal mortality, but associations with other neonatal morbidities remain understudied. We examined the association between abruption and newborn outcomes. We analyzed 223,341 singleton deliveries from the Consortium on Safe Labor study, a retrospective, multisite, observational study (2002-2008) of electronic medical records in the United States. Adjusted relative risks, incidence rate ratios, and 99% confidence intervals were estimated. Direct effects attributable to abruption were examined by conditioning on intermediates (preterm birth and small for gestational age) with sensitivity analyses. Incidence of abruption was 1.6% (n = 3,619). Abruption was associated with an elevated risk of newborn resuscitation (relative risk (RR) = 1.5, 99% confidence interval (CI): 1.5, 1.6), apnea (RR = 5.8, 99% CI: 5.1, 6.5), asphyxia (RR = 8.5, 99% CI: 5.7, 11.3), respiratory distress syndrome (RR = 6.5, 99% CI: 5.9, 7.1), neonatal intensive care unit admission (RR = 3.4, 99% CI: 3.2, 3.6), longer intensive care length of stay (incidence rate ratio = 2.0, 99% CI: 1.9, 2.2), stillbirth (RR = 6.3, 99% CI: 4.7, 7.9), and neonatal mortality (RR = 7.6, 99% CI: 5.2, 10.1). In sensitivity analyses, there was a direct effect of abruption associated with increased neonatal risks. These findings expand our knowledge of the association between abruption and perinatal and neonatal outcomes.

Noninvasive blood tests for fetal development predict gestational age and preterm delivery

Toward more predictable birthdays Low-cost methods for monitoring fetal development could improve prenatal care, especially in low-resource settings. By measuring the levels of certain placental RNA transcripts in maternal blood, Ngo et al. developed two noninvasive blood tests that provide a window into the progression of individual pregnancies. In a small proof-of-concept study, the first blood test predicted fetal age and delivery date with an accuracy comparable to that of ultrasound. The second blood test, also examined in a small pilot study, discriminated women at risk of preterm delivery from those who delivered at full term. The next step will be to assess the reliability of the tests in large, blinded clinical trials. Science, this issue p. 1133 In pilot studies of pregnant women, RNA-based tests of maternal blood predicted delivery date and risk of early childbirth. Noninvasive blood tests that provide information about fetal development and gestational age could potentially improve prenatal care. Ultrasound, the current gold standard, is not always affordable in low-resource settings and does not predict spontaneous preterm birth, a leading cause of infant death. In a pilot study of 31 healthy pregnant women, we found that measurement of nine cell-free RNA (cfRNA) transcripts in maternal blood predicted gestational age with comparable accuracy to ultrasound but at substantially lower cost. In a related study of 38 women (25 full-term and 13 preterm deliveries), all at elevated risk of delivering preterm, we identified seven cfRNA transcripts that accurately classified women who delivered preterm up to 2 months in advance of labor. These tests hold promise for prenatal care in both the developed and developing worlds, although they require validation in larger, blinded clinical trials.

Prophylactic Wound Vacuum Therapy after Cesarean Section to Prevent Wound Complications in the Obese Population: A Randomized Controlled Trial (the ProVac Study)

Objective The objective of this study was to perform a randomized controlled feasibility trial investigating negative pressure wound therapy (NPWT) system versus a standard postcesarean wound care (WC) on the development of a postoperative surgical site infection (SSI) and/or a wound dehiscence in obese women. Study Design This is a randomized controlled feasibility trial of obese women undergoing an unscheduled cesarean delivery. Women with an initial body mass index ≥ 30 kg/m2 who were ≥ 4 cm dilated were included. Women were assigned to either a NPWT or standard WC. The primary outcome was a composite of wound morbidity at 4 weeks postpartum including SSI and/or wound opening (clinicaltrials.gov, NCT02128997). Continuous variables were analyzed with t‐test and Wilcoxon rank‐sum tests and categorical variables with Fishers exact test. Results Of 136 women randomized, 67 received NPWT and 69 received standard WC. The 4‐week follow‐up rate was 88%. Maternal clinical and surgical characteristics were similar between the groups. The prevalence of the composite wound morbidity outcome was not different between those with NPWT and standard WC (4.9 vs. 6.9%; p = 0.71). Conclusion Routine clinical use of a NPWT system after cesarean delivery did not result in a significant reduction of wound morbidity over standard WC.

Maternal, Labor, Delivery, and Perinatal Outcomes Associated with Placental Abruption: A Systematic Review

Objective Risk factors for placental abruption have changed, but there has not been an updated systematic review investigating outcomes. Methods We searched PubMed, EMBASE, Web of Science, SCOPUS, and CINAHL for publications from January 1, 2005 through December 31, 2016. We reviewed English‐language publications reporting estimated incidence and/or risk factors for maternal, labor, delivery, and perinatal outcomes associated with abruption. We excluded case studies, conference abstracts, and studies that lacked a referent/comparison group or did not clearly characterize placental abruption. Results A total of 123 studies were included. Abruption was associated with elevated risk of cesarean delivery, postpartum hemorrhage and transfusion, preterm birth, intrauterine growth restriction or low birth weight, perinatal mortality, and cerebral palsy. Additional maternal outcomes included relaparotomy, hysterectomy, sepsis, amniotic fluid embolism, venous thromboembolism, acute kidney injury, and maternal intensive care unit admission. Additional perinatal outcomes included acidosis, encephalopathy, severe respiratory disorders, necrotizing enterocolitis, acute kidney injury, need for resuscitation, chronic lung disease, infant death, and epilepsy. Conclusion Few studies examined outcomes beyond the initial birth period, but there is evidence that both mother and child are at risk of additional adverse outcomes. There was also considerable variation in, or absence of, the reporting of abruption definitions.

A validated calculator to estimate risk of cesarean after an induction of labor with an unfavorable cervix

Background Induction of labor occurs in >20% of pregnancies, which equates to approximately 1 million women undergoing an induction in the United States annually. Regardless of how common inductions are, our ability to predict induction success is limited. Although multiple risk factors for a failed induction have been identified, risk factors alone are not enough to quantify an actual risk of cesarean for an individual woman undergoing a cesarean. Objective The objective of this study was to derive and validate a prediction model for cesarean after induction with an unfavorable cervix and to create a Web‐based calculator to assist in patient counseling. Study Design Derivation and validation of a prediction model for cesarean delivery after induction was performed as part of a planned secondary analysis of a large randomized trial. A predictive model for cesarean delivery was derived using multivariable logistic regression from a large randomized trial on induction methods (n = 491) that took place from 2013 through 2015 at an academic institution. Full‐term (≥37 weeks) women carrying a singleton gestation with intact membranes and an unfavorable cervix (Bishop score ≤6 and dilation ≤2 cm) undergoing an induction were included in this trial. Both nulliparous and multiparous women were included. Women with a prior cesarean were excluded. Refinement of the prediction model was performed using an observational cohort of women from the same institution who underwent an induction (n = 364) during the trial period. An external validation was performed utilizing a publicly available database (Consortium for Safe Labor) that includes information for >200,000 deliveries from 19 hospitals across the United States from 2002 through 2008. After applying the same inclusion and exclusion criteria utilized in the derivation cohort, a total of 8466 women remained for analysis. The discriminative power of each model was assessed using a bootstrap, bias‐corrected area under the curve. Results The cesarean delivery rates in the derivation and external validation groups were: 27.7% (n = 136/491) and 26.4% (n = 2235/8466). In multivariable modeling, nulliparity, gestation age ≥40 weeks, body mass index at delivery, modified Bishop score, and height were significantly associated with cesarean. A nomogram and calculator were created and found to have an area under the curve in the external validation cohort of 0.73 (95% confidence interval, 0.72–0.74). Conclusion A nomogram and user‐friendly Web‐based calculator that incorporates 5 variables known at the start of induction has been developed and validated. It can be found at: http://www.uphs.upenn.edu/obgyn/labor‐induction‐calculator/. This calculator can be used to augment patient counseling for women undergoing an induction with an unfavorable cervix.

Quantitative fetal fibronectin and cervical length in symptomatic women: results from a prospective blinded cohort study*

Abstract Objectives: Our objectives were to determine whether quantitative fetal fibronectin (fFN) and cervical length (CL) screening can be used alone or in combination as prognostic tests to identify symptomatic women at the highest or lowest risk for spontaneous preterm birth (sPTB). Methods: A prospective, blinded cohort study of women presenting with a singleton gestation to our triage unit between 22-33w6d with preterm labor symptoms was performed. Women with ruptured membranes, moderate/severe bleeding, and dilation >2 cm were excluded. The primary outcome was sPTB <37 weeks. We evaluated test characteristics of quantitative fFN and CL assessment, both separately and in combination, considering traditionally reported cut-points (fFN ≥50 and CL <25), as well as cut-points above and below these measures. We found interactions between fFN >50 and CL <25 and sPTB by parity and obstetric history (p < .05) and therefore stratified results. Test characteristics are presented with positive predictive value (PPV) and negative predictive value (NPV). Results: Five hundred eighty women were enrolled and 537 women were available for analysis. Overall sPTB rate was 11.1%. Among nulliparous women, increasing levels of fFN were associated with increasing risk of sPTB, with PPV going from 26.5% at ≥20 ng/mL to 44.4% at ≥200 ng/mL. A cut-point of 20 ng/mL had higher sensitivity (69.2%) and higher NPV (96.8%) and therefore identified a “low-risk” group. fFN was not informative for multiparous women regardless of prior obstetrical history or quantitative level chosen. For all women, a shorter CL was associated with an increased sPTB risk. Among nulliparas and multiparas without a prior sPTB, a CL <20 mm optimized test characteristics (PPV 25 and 20%, NPV 95.5, and 92.7%, respectively). For multiparas with a prior sPTB, CL <25 mm was more useful. Using fFN and CL in combination for nulliparas did not improve test characteristics over using the individual fFN (p = .74) and CL (p = .31) components separately. Conclusions: This study identifies the importance of stratifying by parity and obstetrical history when using screening modalities for risk assessment in symptomatic women. For nulliparous women, either quantitative fFN or cervical length assessment can be utilized, depending on resources available, but a lower cut-point of 20 ng/mL should be used for quantitative fFN. For multiparous women, fFN is not useful and cervical length assessment should be the main screening tool utilized when there is clinical uncertainty. Regardless of parity, the PPV of fFN and CL is low and therefore the greatest clinical utility remains in its NPV.

Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial

Background Monitoring blood pressure at 72 hours and 7–10 days post partum in women with hypertensive disorders is recommended to decrease morbidity. However, there are no recommendations as to how to achieve this. Objective To compare the effectiveness of text-based blood pressure monitoring to in-person visits for women with hypertensive disorders of pregnancy in the immediate postpartum period. Methods Randomised clinical trial among 206 postpartum women with pregnancy-related hypertension diagnosed during the delivery admission between August 2016 and January 2017. Women were randomised to 2 weeks of text-based surveillance using a home blood pressure cuff and previously tested automated platform or usual care blood pressure check at their prenatal clinic 4–6 days following discharge. The primary study outcome was a single recorded blood pressure in the first 10 days post partum. The ability to meet American Congress of Obstetricians and Gynecologists (ACOG) guidelines, defined as having a blood pressure recorded on postpartum days 3–4 and 7–10 was evaluated in the text message group. The study was powered to detect a 1.4-fold increase in a single recorded blood pressure using text messaging. All outcomes were analysed as intention to treat. Results 206 women were randomised (103 in each arm). Baseline characteristics were similar. There was a statistically significant increase in a single blood pressure obtained in the texting group in the first 10 days post partum as compared with the office group (92.2% vs 43.7%; adjusted OR 58.2 (16.2–208.1), p<0.001). Eighty-four per cent of patients undergoing text-based surveillance met ACOG criteria for blood pressures at both recommended points. Conclusions Text-based monitoring is more effective in obtaining blood pressures and meeting current clinical guidelines in the immediate postdischarge period in women with pregnancy-related hypertension compared with traditional office-based follow-up. Trial registration number NCT03185455, Remote Surveillance of Postpartum Hypertension (TextBP), https://clinicaltrials.gov.

Short Maternal Stature and Increased Risk of Ischaemic Placental Disease: Is the Association Driven by Unmeasured Confounding?

Katheryne L. Downes, Cande V. Ananth Maternal and Child Health Research Center, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY Department of Epidemiology, Joseph L. Mailman School of Public Health, Columbia University, New York, NY

Attitudes and Knowledge About Breastfeeding Among Obstetrics and Gynecology Residents

INTRODUCTION: Breastfeeding is the preferred method of infant nutrition as a result of the multiple known health benefits to both the infant and mother. Existing literature has shown that implementation of a breastfeeding curriculum among residents increases both resident knowledge as well as breastfeeding rates in their patient populations. These data are limited, however, among obstetrics–gynecology residents. This study was designed to assess knowledge, attitudes, and educational experiences among obstetrics–gynecology residents in regard to breastfeeding. METHODS: A 23-question web-based survey was distributed to all residents from U.S. obstetrics–gynecology residencies. RESULTS: Three hundred fifty-one residents completed the survey showing that although 93% of survey participants agree that breastfeeding education was an important use of their time, poor knowledge regarding breastfeeding was found across all levels of training. Personal or spousal experience with breastfeeding played a significant role in a residents ability to teach a mother how to breastfeed or how to use a breast pump (P<.001). Only 27% of fourth-year residents report ever having hands-on or simulation training on breastfeeding during their residency, and only 37% believe they have had adequate teaching in breastfeeding. CONCLUSIONS: Whereas obstetrics–gynecology residents are highly supportive of breastfeeding, the majority of graduating residents feel that their training curriculum was deficient in the core concepts of this topic. Stronger efforts are needed in residency programs to make breastfeeding education a priority to benefit both the residents and their patients.