Status:
COMPLETED
A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity
Lead Sponsor:
Ohio State University
Conditions:
Pregnant Patients With Obesity
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
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 obesit...
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' ...
Eligibility Criteria
Inclusion
- Nulliparity
- Maternal age \>18 years
- Gestational age ≥37w0d
- 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.
- Singleton gestation
- Cephalic presentation
- Indication for oxytocin use in the first stage of labor
- No contraindication to labor or vaginal delivery
- 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
- Cervical dilation ≤4 cm at time of initiation of induction
Exclusion
- Fetal demise
- Major fetal congenital malformation or known chromosomal abnormality
- Prior uterine surgery (e.g., cesarean, myomectomy)
- Non-reassuring fetal wellbeing as indication for induction
- Intraamniotic infection suspected or diagnosed prior to randomization
- Non-English
- Multifetal gestation
- Gestational age \<37 weeks
- Spontaneous labor
- Cervical dilation \> 4 cm at initiation of induction
- Initiation of oxytocin in the second stage of labor
- Use of oxytocin prior to randomization or planned use of oxytocin with foley catheter for cervical ripening
- Fetal malpresentation
- Estimated fetal weight \>4500 g in a patient with diabetes, or estimated fetal weight \>5000 g in a non-diabetic patient
- Abnormal placentation (e.g. previa, suspected placenta accreta spectrum)
- Physician/provider or patient refusal
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05289869
Start Date
April 6 2022
End Date
October 28 2022
Last Update
November 29 2023
Active Locations (1)
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1
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210