Phase 4
N=140
Oxytocin Dosage to Decrease Induction Duration
Obesity · Labor, Induced · Oxytocin
Bottom Line
View on ClinicalTrials.gov: NCT03140488 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Length of Time to Delivery — 796; 694; 715; 762 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxytocin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Arizona
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Time to Delivery |
796; 694; 715; 762 | — |
| SECONDARY Maximum Oxytocin Infusion Rate |
14.85; 33.00; 17.14; 39.60 | — |
| SECONDARY Number of Participants With Terbutaline Use |
0; 0; 0; 1 | — |
| SECONDARY Rate of Cesarean Delivery |
5; 2; 4; 1 | — |
| SECONDARY Rate of Cesarean Delivery for Labor Arrest |
1; 1; 3; 0 | — |
| SECONDARY Maternal Blood Loss |
391.14; 358.57; 404.29; 491.43 | — |
| SECONDARY Number of Neonates With Apgar Score <7 |
0; 3; 0; 1 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03140488). 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.