BMI-Associated Labor Induction: A Prospective Trial

NCT ID: NCT04035382

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2022-12-31

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

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).

Conditions

Labor Induction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Labor induction

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Foley catheter; Misoprostol; Oxytocin; Amniotomy

Eligibility Criteria

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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Baystate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corina Schoen, MD

Role: PRINCIPAL_INVESTIGATOR

Baystate Medical Center

Locations

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status: RECRUITING

Sidney Kimmel Medical College, Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Corina Schoen, MD

Role: CONTACT

Corina.SchoenMD@baystatehealth.org

413-794-3470

Laura Gebhardt, BA, CCRP

Role: CONTACT

laura.gebhardt@baystatehealth.org

413-794-2706

Facility Contacts

Corina Schoen, MD

Role: primary

Corina.SchoenMD@baystatehealth.org

413-794-2470

Laura Gebhardt, BA, CCRP

Role: backup

laura.gebhardt@baystatehealth.org

413-794-2706

Rupsa Boelig, MD

Role: primary

rupsa.boelig@jefferson.edu

215-995-9196

Other Identifiers

BH-19-000

Identifier Type: -

Identifier Source: org_study_id