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Oxytocin Rest to Reduce Cesarean Delivery

Plain-language guide to NCT06268431: not phased randomized trial of Oxytocin, 350 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06268431
Phase
not phased
Status
recruiting participants
Start
2024-03-19
Completion (planned or actual)
2026-02-15
Participants
350 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Prolonged Labor; Failed Induction; Labor Dystocia
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Oxytocin.

Prolonged labor is usually managed with continuous oxytocin infusion. "Oxytocin rest" has been proposed as a strategy to resolve protracted labor in patients who have received continuous oxytocin without progress.

Yet, there is no randomized or prospective data to support the practice.

It had two arms (groups): 60-minute oxytocin rest (experimental) and Usual care with continuous oxytocin infusion (no intervention).

The registry classes the interventions as other.

More on the Plan

As secondary aims, this trial will also assess the impact of 60-minute oxytocin rest on: measures of the length of labor, risk for adverse maternal and neonatal outcomes, and measures of patient autonomy and sense of control.

The investigators will enroll 350 patients with singleton pregnancies at ≥36 weeks gestation with prolonged labor in the latent phase, defined as cervical dilation \<6cm after ≥8 hours since rupture of membranes and on continuous oxytocin.

Both nulliparous and multiparous individuals undergoing induction or augmentation of labor will be included.

Patients with any contraindication to continuous oxytocin at randomization, or for whom cesarean section is anticipated at randomization will be excluded.

Who Took Part

350 planned participants were the target.

It was open to women only aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: ≥18 years of age. Singleton gestation in vertex presentation. ≥36 weeks gestation. Prolonged latent labor, defined as cervical dilation \<6cm after ≥8 hours since rupture of membranes and on continuous oxytocin.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: not meeting the above criteria; any contraindication to continuous oxytocin at time of randomization; cesarean section anticipated by the clinical team at time of randomization (for any reason excepting labor dystocia).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 2024-03-19 with completion listed for 2026-02-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Cesarean rate (time frame: At time of delivery).

It also tracked 10 secondary outcomes, for example Time to delivery (hours), Time to vaginal delivery (hours), Time to active labor (hours), Duration of active labor (hours), Composite maternal adverse outcome and Composite neonatal adverse outcome.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 350 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.