A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity
Condition: Pregnant Patients With Obesity
MeSH terms: Obesity
Intervention: High-dose oxytocin; Low-dose oxytocin
Intervention description: 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.; 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 MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Participants, research staff, and clinical care providers will be blinded to the dosing regimen.
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Oxytocin; Pregnant patients with obesity; Induction of labor

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:

          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