Status:
UNKNOWN
BMI-Associated Labor Induction: A Prospective Trial
Lead Sponsor:
Baystate Medical Center
Conditions:
Labor Induction
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ex...
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 in...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04035382
Start Date
October 31 2019
End Date
December 31 2022
Last Update
April 13 2022
Active Locations (2)
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1
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
2
Sidney Kimmel Medical College, Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107