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

Baystate Medical Center

Status: Unknown

Conditions: Labor Induction

Treatments: Procedure: Labor induction

Study type: Interventional

Funder types: Other

Identifiers

NCT04035382

BH-19-000

Details and patient eligibility

About

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

Full 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).

Enrollment: 82 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18 years and older
2. Pregnant, singleton gestation, vertex presentation
3. Nulliparous (no prior pregnancy delivered past 20 weeks)
4. 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
5. 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

1. Plan for induction of labor prior to 41 weeks 0 days for medical indication prior to study consideration

2. Plan for cesarean delivery or contraindication to labor

3. 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)

4. Multiple gestation

5. Non-vertex presentation

6. Fetal death

7. 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

8. Fetal growth restriction (EFW <10th percentile or AC <10th percentile)

9. Preeclampsia or gestational hypertension

10. Known oligohydramnios or polyhydramnios

11. Prior delivery after 20 weeks

12. Placenta/vasa previa

13. Placental abruption (known or suspected) or unexplained vaginal bleeding

14. Previous cesarean section, myomectomy, or classical cesarean

15. Spontaneous labor or suspicion of labor with regular contractions and cervical change, rupture membranes

16. Active genital herpes or HIV positive

17. Inability to consent

18. Any contraindication to a vaginal delivery

19. Delivery anticipated outside of Baystate Medical Center

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

Labor Induction

Experimental group

Description:

Induction of labor between 39 0/7 to 39 6/7 weeks. Cervical ripening and induction method will be left to the managing clinician. However, combination method of cervical ripening with prostaglandin or oxytocin and Foley catheter, followed by oxytocin infusion and amniotomy will be encouraged.

Treatment:

Procedure: Labor induction