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

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

Study Overview

• Status: Recruiting
• Conditions: Labor Induction
• Intervention / Treatment: Procedure: Labor induction

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).

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corina Schoen, MD; Phone Number: 413-794-3470; Email: Corina.SchoenMD@baystatehealth.org
• Study Contact Backup: Name: Laura Gebhardt, BA, CCRP; Phone Number: 413-794-2706; Email: laura.gebhardt@baystatehealth.org

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Recruiting
      • Baystate Medical Center
      • Contact: Laura Gebhardt, BA, CCRP; Phone Number: 413-794-2706; Email: laura.gebhardt@baystatehealth.org
      • Contact: Corina Schoen, MD; Phone Number: 413-794-2470; Email: Corina.SchoenMD@baystatehealth.org
      • Principal Investigator: Corina Schoen, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Sidney Kimmel Medical College, Thomas Jefferson University
      • Contact: Rupsa Boelig, MD; Phone Number: 215-995-9196; Email: rupsa.boelig@jefferson.edu
      • Principal Investigator: Rupsa Boelig, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Labor Induction; 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.

Procedure: Labor induction; The study intervention is labor induction from 39 0/7 to 39 6/7 weeks. The individual labor induction process will be at the discretion of the physician or midwife managing the subject's care. Methods of induction that may be used include misoprostol, intracervical Foley catheter, oxytocin, and/or amniotomy. Participating clinicians will be encouraged to use only one course of cervical ripening followed by oxytocin infusion and amniotomy.; Other Names: Oxytocin; Foley catheter; Misoprostol; Amniotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of cesarean section	The primary outcome is to determine whether planned induction of labor at 39 weeks for obese nulliparous women changes the incidence of cesarean section.	Admission for induction to discharge from delivery admission, up to 3 weeks after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incisional extensions at cesarean section	J or T shape incisions or cervical trauma	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Operative vaginal delivery and indication	Vacuum or forceps	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Suspected intraamniotic infection	At least one maternal fever ≥100.4 F with at least one additional clinical sign of maternal tachycardia, fetal tachycardia, uterine tenderness or purulent/foul smelling vaginal discharge	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.
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.
Preeclampsia	Preeclampsia without severe features: Elevated blood pressure after 20 weeks ≥140/90 on 2 occasions at least 4 hours apart with previously normal blood pressure AND,; proteinuria (≥300 mg per 24 hours collection OR ≥0.3 mg/dL on protein:creatinine ratio OR 1+ on dipstick if neither of the previous is available) Preeclampsia with severe features: Elevated blood pressure after 20 weeks ≥160/110 on 2 occasions (may be within minutes to ensure medication treatment) OR,; Blood pressure ≥140/90 and systemic findings including: new platelet count <100,000microliter, serum creatinine >1.1 mg/dL, doubling of serum creatinine in absence of other renal disease, liver transaminases twice upper limit of normal, pulmonary edema, cerebral or visual symptoms; Proteinuria is not necessary for this diagnosis Eclampsia: preeclampsia with eclamptic seizure	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Gestational hypertension	Gestational hypertension: blood pressure elevation ≥140/90 on two occasions after 20 weeks in absence of proteinuria or systemic findings defined above	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Postpartum hemorrhage	Visual estimated blood loss >1000 mL or need for two or more uterotonics	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.
Composite maternal infectious outcome	Endometritis, wound reopened for hematoma, seroma, infection, or other reasons, cellulitis requiring antibiotics, pneumonia, pyelonephritis, bacteremia of unknown source, septic pelvic thrombosis	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.
Birth weight	Macrosomia >4500 grams, large for gestational age (LGA) defined as 90th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Duration and presence (up to 72 hours) of respiratory support	Including ventilator, CPAP, high-flow nasal cannula (HFNC)	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Small for gestational age	<5th percentile and <10th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data	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.
Shoulder dystocia	Need for additional maneuvers to accomplish delivery	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.
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.
Hyperbilirubinemia requiring phototherapy or exchange transfusion		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.
Neonatal seizures		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Sepsis	Requires the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebrospinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection.	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Neonatal encephalopathy	As defined by Shankaran et al.	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.
Birth trauma	Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage facial nerve injury	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.
Neonatal composite outcome	IUFD, neonatal death, intubation or neonatal respiratory support, Apgar score ≤ 7 at 5 minutes, seizures, sepsis as defined above, neonatal encephalopathy, pneumonia, meconium aspiration syndrome, birth trauma, intracranial hemorrhage, or hypotension	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Hypoglycemia	glucose < 35 mg/dL requiring IV therapy	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.
Number of clinic visits post enrollment to admission for delivery		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.
Intrauterine pressure catheter (IUPC) or fetal scalp electrode placement		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.
Use of induction and ripening agents, maximum dose of oxytocin		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 postpartum length of hospital stay		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.
Post discharge resource utilization	Inpatient and outpatient visits for mother and baby from discharge to 6 weeks	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.

Collaborators and Investigators

• Sponsor: Baystate Medical Center
• Investigators: Principal Investigator: Corina Schoen, MD, Baystate Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Cesarean section; BMI; Labor induction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Oxytocin; Misoprostol
• Other Study ID Numbers: BH-19-000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No