Obesity Clinical Trial
— OPSOfficial title:
High Dose vs. Low Dose Oxytocin for Labor Induction in Obese Women: a Randomized Controlled Trial - the OPS (Obese Pitocin Study) Trial
Verified date | November 2022 |
Source | University of Arizona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | September 5, 2019 |
Est. primary completion date | October 12, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Banner University Medical Center Tucson | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of Time to Delivery | Number of minutes from induction of labor with oxytocin infusion to delivery of infant, no maximum amount of time specified. | Start of induction to Delivery | |
Secondary | Maximum Oxytocin Infusion Rate | rate measured in milliunits/minute during induction of labour, no time limit applied. | Start of induction to Delivery | |
Secondary | Number of Participants With Terbutaline Use | If terbutaline was injected during labor to decrease number or strength of contraction | Start of induction to Delivery | |
Secondary | Rate of Cesarean Delivery | total number of patients who undergo cesarean delivery | Start of induction to Delivery | |
Secondary | Rate of Cesarean Delivery for Labor Arrest | Number of patients who undergo cesarean delivery due to labor arrest/ failed induction | Start of induction to Delivery | |
Secondary | Maternal Blood Loss | Blood loss in milliliters | At delivery | |
Secondary | Number of Neonates With Apgar Score <7 | 5 minute Apgar Score <7
*Apgar is an acronym for which each criterion is given a minimum of 0 and maximum of 2 points: Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), Respiration |
5 minutes after birth |
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