Recruiting

Observational Study

Sponsor:

Baystate Medical Center

Code:

NCT04035382

Conditions

Labor Induction

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Labor induction

Study Details

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

Study ID

NCT04035382

Start date

Oct 31, 2019

Status verified date

Apr, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Sep 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

82 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Incidence of cesarean section [ Time Frame: Admission for induction to discharge from delivery admission, up to 3 weeks after enrollment. ]

Central Contacts and Locations

Central contacts

Corina Schoen, MD

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

Laura Gebhardt, BA, CCRP

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

Locations

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

Corina Schoen, MD

413-794-2470Corina.SchoenMD@baystatehealth.org

Laura Gebhardt, BA, CCRP

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

Principal Investigator:

Corina Schoen, MD

Sidney Kimmel Medical College, Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Rupsa Boelig, MD

215-995-9196rupsa.boelig@jefferson.edu

Principal Investigator:

Rupsa Boelig, MD

More Information

Sponsor

Baystate Medical Center

Last update posted

Apr 13, 2022

Last verified

Apr, 2022

Keywords

  • BMI
  • Obesity
  • Labor induction
  • Cesarean section

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Baystate Medical Center on 2022-04-13.