A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity

NCT ID: NCT05289869

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2022-10-28

Brief Summary

Pregnant patients with obesity are more likely to undergo induction of labor and have a higher risk of failed induction compared to patients with normal weight. The association between maternal obesity and labor dysfunction leading to cesarean delivery is poorly understood. Oxytocin is the mostly common medication used in induction of labor, yet optimal dosing of this medication is unknown. Studies have suggested that patients with obesity may be less responsive to oxytocin. This trial will compare a high and low dose oxytocin dosing regimen for the induction of labor in women with obesity.

Detailed Description

This study is a pragmatic single center randomized, double blinded controlled trial. Nulliparous women with a pre-pregnancy body mass index (BMI) ≥30 kg/m2 undergoing induction of labor at ≥37 weeks' gestation will be eligible for enrollment. Women will be randomly allocated to receive oxytocin using either a high-dose or low-dose regimen. Patients, providers, and research staff will be blinded to the dosing regimen. All other aspects of obstetric management will be at the discretion of the patient's clinical care team.

Postpartum maternal, neonatal, and delivery outcomes will be collected. Postpartum data through hospital discharge will be collected from the medical record. Information about complications following hospital discharge through 6 weeks after delivery will be collected during a research follow-up telephone call performed 6-8 weeks following delivery.

Conditions

Pregnant Patients With Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

High-dose oxytocin regimen

Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.

Group Type: EXPERIMENTAL

High-dose oxytocin

Intervention Type: DRUG

Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.

Low-dose oxytocin regimen

Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.

Group Type: EXPERIMENTAL

Low-dose oxytocin

Intervention Type: DRUG

Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.

Interventions

High-dose oxytocin

Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.

Intervention Type: DRUG

Low-dose oxytocin

Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Nulliparity

2. Maternal age >18 years

3. Gestational age ≥37w0d

4. Induction of labor, defined as initiation of labor with medication or intracervical Foley catheter in a patient without observed spontaneous cervical change and <6 contractions per hour (average of one contraction every 10 minutes) at the time of initial presentation. Women with prelabor rupture of membranes (PROM) can be included if the other criteria are also met with regards to cervical dilation and contractions.

5. Singleton gestation

6. Cephalic presentation

7. Indication for oxytocin use in the first stage of labor

8. No contraindication to labor or vaginal delivery

9. Pre-pregnancy BMI ≥30 kg/m2 based on patient report and confirmed by pre-pregnancy or first trimester weight as recorded in the medical record

10. Cervical dilation ≤4 cm at time of initiation of induction

Exclusion Criteria

1. Fetal demise

2. Major fetal congenital malformation or known chromosomal abnormality

3. Prior uterine surgery (e.g., cesarean, myomectomy)

4. Non-reassuring fetal wellbeing as indication for induction

5. Intraamniotic infection suspected or diagnosed prior to randomization

6. Non-English

7. Multifetal gestation

8. Gestational age <37 weeks

9. Spontaneous labor

10. Cervical dilation > 4 cm at initiation of induction

11. Initiation of oxytocin in the second stage of labor

12. Use of oxytocin prior to randomization or planned use of oxytocin with foley catheter for cervical ripening

13. Fetal malpresentation

14. Estimated fetal weight >4500 g in a patient with diabetes, or estimated fetal weight >5000 g in a non-diabetic patient

15. Abnormal placentation (e.g. previa, suspected placenta accreta spectrum)

16. Physician/provider or patient refusal

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Heather Frey

MD, MSCI, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021H0432

Identifier Type: -

Identifier Source: org_study_id