BMI-Associated Labor Induction: A Prospective Trial (BALI)

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    82
  • sponsor
    Baystate Medical Center
Updated on 1 May 2022
cesarean section
Accepts healthy volunteers

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

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).

Details
Condition Labor Induction
Treatment Labor induction, Labor induction
Clinical Study IdentifierNCT04035382
SponsorBaystate Medical Center
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

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)
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
Known oligohydramnios or polyhydramnios
Prior delivery after 20 weeks
Placenta/vasa previa
Placental abruption (known or suspected) or unexplained vaginal bleeding
Previous cesarean section, myomectomy, or classical cesarean
Spontaneous labor or suspicion of labor with regular contractions and cervical change, rupture membranes
Active genital herpes or HIV positive
Inability to consent
Any contraindication to a vaginal delivery
Delivery anticipated outside of Baystate Medical Center
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