BMI-Associated Labor Induction: A Prospective Trial

NCT04035382 | Unknown DMC

• 1 other identifier: BH-19-000
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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

Conditions

Labor Induction

Keywords

BMI; Obesity; Labor induction; Cesarean section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (43)

• Incisional extensions at cesarean section

  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.

• 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.

Study Arms (1)

Labor Induction

EXPERIMENTAL

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

Interventions

Labor induction PROCEDURE

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.

Also known as: Foley catheter, Misoprostol, Oxytocin, Amniotomy

Labor Induction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (2)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

Sidney Kimmel Medical College, Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Labor, Induced; Misoprostol; Oxytocin; Amniotomy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Corina Schoen, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corina Schoen, MD

CONTACT

413-794-3470; Corina.SchoenMD@baystatehealth.org

Laura Gebhardt, BA, CCRP

CONTACT

413-794-2706; laura.gebhardt@baystatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Simon two-stage

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 29, 2019
• Study Start: October 31, 2019
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)