BMI-Associated Labor Induction: A Prospective Trial

Baystate Medical Center2 sites in 1 country82 target enrollmentOctober 31, 2019

ConditionsLabor Induction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Labor Induction
Sponsor: Baystate Medical Center
Enrollment: 82
Locations: 2
Primary Endpoint: Incidence of cesarean section
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to determine if planned induction of labor at 39 weeks for nulliparous with pre-pregnancy BMI ≥ 35 kg/m2 reduces the incidence of cesarean section compared to expectant management

Detailed Description

Obesity in the obstetric population has reached epidemic proportions, affecting over 30% of reproductive-aged women in the United States (1). The increase in this morbidity is associated with large increases in cesarean delivery over the non-obese obstetric population and resultant post-operative complications are also higher in obese women (2). There are no interventions proven to reduce the risk of cesarean in obese women. The aim of this research study is to determine if induction of labor at 39 weeks can reduce the incidence of cesarean delivery over routine obstetric care (expectant management).

Registry

clinicaltrials.gov

Start Date

October 31, 2019

End Date

December 31, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Baystate Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 years and older
•Pregnant, singleton gestation, vertex presentation
•Nulliparous (no prior pregnancy delivered past 20 weeks)
•Pre-pregnancy (self-reported in record of in EMR within 3 months of LMP) or 1st trimester (up to and including 14 weeks 0 days) BMI ≥ 35 kg/m2
•Gestational age at enrollment 38 weeks 0 days and 38 weeks 6 days with dating confirmed by LMP and ultrasound performed prior to 20 6/7 weeks

Exclusion Criteria

•Plan for induction of labor prior to 41 weeks 0 days for medical indication prior to study consideration
•Plan for cesarean delivery or contraindication to labor
•Major illness with increased risk of adverse pregnancy outcomes (e.g. pregestational diabetes with or without medication, gestational diabetes on medication, hypertension, cardiac disease, renal insufficiency, autoimmune disorder)
•Multiple gestation
•Non-vertex presentation
•Fetal death
•Fetus with major/lethal anomaly or aneuploidy (soft markers of aneuploidy, urinary tract dilation, isolated bowel dilation, mild ventriculomegaly, normal variants of vascular system, and isolated ventricular septal defects will not be excluded)
•a. Soft markers not qualifying as exclusion criteria: echogenic intracardiac focus, choroid plexus cyst, echogenic bowel, increased NT or nuchal fold, isolate short humerus or femur
•Fetal growth restriction (EFW \<10th percentile or AC \<10th percentile)
•Preeclampsia or gestational hypertension

Outcomes

Primary Outcomes

Incidence of cesarean section

Time Frame: Admission for induction to discharge from delivery admission, up to 3 weeks after enrollment.

The primary outcome is to determine whether planned induction of labor at 39 weeks for obese nulliparous women changes the incidence of cesarean section.

Secondary Outcomes

Postpartum hemorrhage(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Suspected intraamniotic infection(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
3rd or 4th degree perineal laceration(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Maternal death(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Operative vaginal delivery and indication(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Composite maternal infectious outcome(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Incisional extensions at cesarean section(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Antepartum, intrapartum, or neonatal death(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Admission to the intensive care unit (ICU)(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Postpartum endometritis(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Duration and presence (up to 72 hours) of respiratory support(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Small for gestational age(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Hyperbilirubinemia requiring phototherapy or exchange transfusion(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Neonatal encephalopathy(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Hypoglycemia(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Use of induction and ripening agents, maximum dose of oxytocin(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Preeclampsia(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Shoulder dystocia(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Sepsis(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Neonatal composite outcome(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Admission to the neonatal intensive care unit (NICU)(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Epidural use(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Neonatal length of hospital stay(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Length of NICU or intermediate care stay(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Gestational hypertension(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Birth weight(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Cephalohematoma(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Apgar ≤ 7 at 5 minutes(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Number of clinic visits post enrollment to admission for delivery(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Number of hours on labor and delivery unit(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Maternal venous thromboembolism(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Breastfeeding intention and initiation in the hospital(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Breastfeeding at 6 weeks (exclusive and any breastfeeding)(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Birth trauma(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Intrauterine pressure catheter (IUPC) or fetal scalp electrode placement(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Maternal postpartum length of hospital stay(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Post discharge resource utilization(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Transfusion of blood products(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Neonatal seizures(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Meconium aspiration syndrome(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Intracranial hemorrhage or subgaleal hemorrhage(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Neonatal hypotension requiring pressor support(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)
Non-stress tests, biophysical profiles (BPP), modified BPPs, ultrasounds done other than BPP, Doppler, contraction stress test(From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.)