Phase 4
N=20
A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity
Pregnant Patients With Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05289869 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Number of Participants Delivered by Cesarean — 3; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- High-dose oxytocin (Drug); Low-dose oxytocin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ohio State University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Delivered by Cesarean |
3; 3 | — |
| SECONDARY Duration of Time From Start of Induction to Delivery |
22.6; 24.7 | — |
| SECONDARY Duration of the First Stage of Labor |
17.3; 21.4 | — |
| SECONDARY Occurrence of Tachysystole |
5; 3 | — |
| SECONDARY Incidence of Uterine Rupture |
0; 0 | — |
| SECONDARY Incidence of Clinical Chorioamnionitis |
3; 1 | — |
| SECONDARY Incidence of Postpartum Maternal Infectious Morbidity |
0; 0 | — |
| SECONDARY Incidence of Maternal Death |
0; 0 | — |
| SECONDARY Incidence of Immediate Postpartum Hemorrhage |
0; 1 | — |
| SECONDARY Incidence of Maternal Blood Transfusion |
0; 1 | — |
| SECONDARY Incidence of Maternal ICU Admission |
0; 0 | — |
| SECONDARY Incidence of Composite Neonatal Morbidity Outcomes |
1; 1 | — |
| SECONDARY Incidence of NICU Admission |
1; 2 | — |
| SECONDARY Maternal Length of Stay |
3; 3 | — |
| SECONDARY Neonatal Length of Stay |
2; 2 | — |
| SECONDARY Perception of the Labor, Birth, and Postpartum Experience |
14; 9 | — |
| SECONDARY Labor Agentry Score |
139.5; 185 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT05289869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.