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NCT03140488: OPS

Oxytocin Dosage to Decrease Induction Duration

Completed Phase 4 Results posted Last updated 20 December 2022
What this trial tests

Phase 4 trial testing Oxytocin in Obesity in 140 participants. Completed in 5 September 2019.

Timeline
5 June 2017
Primary endpoint
12 October 2018
5 September 2019

Quick facts

Lead sponsorUniversity of Arizona
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeother
Enrollment140
Start date5 June 2017
Primary completion12 October 2018
Estimated completion5 September 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Arizona

Who can join

18 and older, female only, with Obesity or Labor, Induced. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Length of Time to Delivery Primary · Start of induction to Delivery

Number of minutes from induction of labor with oxytocin infusion to delivery of infant, no maximum amount of time specified.

GroupValue95% CI
Lean-Control796± 411
Lean-Intervention694± 466
Obese-Control715± 497
Obese-Intervention762± 594
Maximum Oxytocin Infusion Rate Secondary · Start of induction to Delivery

rate measured in milliunits/minute during induction of labour, no time limit applied.

GroupValue95% CI
Lean-Control14.85± 7.16
Lean-Intervention33.00± 25.64
Obese-Control17.14± 10.99
Obese-Intervention39.60± 21.09
Number of Participants With Terbutaline Use Secondary · Start of induction to Delivery

If terbutaline was injected during labor to decrease number or strength of contraction

GroupValue95% CI
Lean-Control0
Lean-Intervention0
Obese-Control0
Obese-Intervention1
Rate of Cesarean Delivery Secondary · Start of induction to Delivery

total number of patients who undergo cesarean delivery

GroupValue95% CI
Lean-Control5
Lean-Intervention2
Obese-Control4
Obese-Intervention1
Rate of Cesarean Delivery for Labor Arrest Secondary · Start of induction to Delivery

Number of patients who undergo cesarean delivery due to labor arrest/ failed induction

GroupValue95% CI
Lean-Control1
Lean-Intervention1
Obese-Control3
Obese-Intervention0
Maternal Blood Loss Secondary · At delivery

Blood loss in milliliters

GroupValue95% CI
Lean-Control391.14± 207.96
Lean-Intervention358.57± 166.49
Obese-Control404.29± 226.99
Obese-Intervention491.43± 342.89
Number of Neonates With Apgar Score <7 Secondary · 5 minutes after birth

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

GroupValue95% CI
Lean-Control0
Lean-Intervention3
Obese-Control0
Obese-Intervention1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Oxytocin

Trials testing the same drug.

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other University of Arizona trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03140488.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing