Oxytocin Dosage to Decrease Induction Duration
Condition: Obesity; Labor, Induced; Oxytocin
Intervention: Oxytocin
Intervention description: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 Comparison groups:
Control group: Lean cohort: BMI ≤25, at <20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
Intervention group: Lean cohort: BMI ≤25, at <20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
Control group: Obese cohort: BMI ≥30, at <20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
Intervention group: Obese cohort: BMI ≥30, at <20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: This portion of the study will be carried out by the research pharmacy. Single (low dose) and triple (high dose) concentration of oxytocin will be premixed in the intravenous fluid bag in the pharmacy. Sequence generation for randomization will be created with 1:1 ratio in both the obese and lean group by the Department of Statistics. After the sequence is generated, ths list will be given to the research pharmacy. The premixed oxytocin medication will be sequentially labelled as "OPS drug, patient #1, 2, 3" etc. per the allocation. Allocation concealment will also be carried out by pharmacy as these bags will completely appear identical after they are labelled numerically. Once a patient is randomized, the pharmacy will send up the appropriate concentration of oxytocin already premixed in the intravenous fluid bag, labelled as "OPS drug, patient #". Lean group will be assigned at # 1-70 and obese group will be assigned at #71-140.
Enrollment: 140.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Induction of labor; Pitocin; BMI

Summary:

      This is a randomized controlled trial in which women are allocated either 'high dose' or 'low
      dose' oxytocin infusions for induction of labour. The randomization is stratified by maternal
      body mass index.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Singleton pregnancy ≥ 37 weeks gestation

          -  Patient presented for induction of labor who is determined to be a candidate for
             oxytocin

          -  Cephalic presentation

          -  Reassuring fetal health assessment (no abnormal findings in fetal assessment, see
             below)

          -  Meeting one of the following BMI category:

        Obese group: BMI ≥30 at <20 weeks of pregnancy, or BMI ≥35 at a term gestation of pregnancy
        Lean group: BMI ≤25 at <20 weeks of pregnancy, or BMI ≤28 at a term gestation of pregnancy

        Exclusion Criteria:

          -  Non-reassuring fetal assessment at the time of recruitment

          -  Previous cervical ripening agents (cytotec, cervidil, cervical Foley Balloon)

          -  <18 years of age

          -  Prisoners

          -  Any patients contraindicated for vaginal delivery

          -  Multiple gestations

          -  History of previous cesarean delivery

          -  Patients with history of significant cardiac disease

          -  Fetal demise

          -  Estimated fetal weight greater than 4500 grams in diabetic and 5000 grams in
             non-diabetic mother

          -  Ruptured membranes

          -  Spontaneous labor (latent or active phase)

          -  Augmentation of labor (latent or active phase)