Clinical trial NCT05289869: A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity
Official title: The HILIO Trial: High vs. Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity- PILOT STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnant Patients With Obesity
Keywords: Oxytocin
Pregnant patients with obesity
Induction of labor
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Delivered by Cesarean
timeFrame: Until delivery
Secondary outcomes:
measure: Duration of Time From Start of Induction to Delivery
timeFrame: From start of induction to delivery
measure: Duration of the First Stage of Labor
timeFrame: From start of induction to delivery
measure: Occurrence of Tachysystole
timeFrame: From start of induction to delivery
measure: Incidence of Uterine Rupture
timeFrame: From start of induction to delivery
measure: Incidence of Clinical Chorioamnionitis
timeFrame: From start of induction thorough delivery
measure: Incidence of Postpartum Maternal Infectious Morbidity
timeFrame: Within 6 weeks following delivery
measure: Incidence of Maternal Death
timeFrame: Within 6 weeks of delivery
measure: Incidence of Immediate Postpartum Hemorrhage
timeFrame: Within 24 hours of delivery
measure: Incidence of Maternal Blood Transfusion
timeFrame: From randomization through hospital discharge up to 6 weeks portpartum
measure: Incidence of Maternal ICU Admission
timeFrame: From randomization through 6 weeks postpartum
measure: Incidence of Composite Neonatal Morbidity Outcomes
timeFrame: Within 6 weeks of delivery
measure: Incidence of NICU Admission
timeFrame: Within 6 weeks of delivery
measure: Maternal Length of Stay
timeFrame: Within 6 weeks of delivery
measure: Neonatal Length of Stay
timeFrame: Within 6 weeks of delivery
measure: Perception of the Labor, Birth, and Postpartum Experience
timeFrame: Assessed within 12-96 hours after delivery
measure: Labor Agentry Score
timeFrame: Assessed within 12-96 hours after delivery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
References: