The HILIO Trial: High vs. Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity- PILOT STUDY

2021H0432

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.

2022-04-06

2022-09-18

2022-10-28

Completed

Early phase I

20

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

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2023-11-29