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Different Medications to Induce Labor

Plain-language guide to NCT06259097: phase 3 randomized trial of Oxytocin, 303 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06259097
Phase
phase 3
Status
completed
Start
2024-07-02
Completion (planned or actual)
2026-08-10
Participants
303 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Pregnancy; Labor
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Oxytocin.

It had two arms (groups): Misoprostol and Pitocin (active comparator) and Pitocin only (active comparator).

Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.

Patient receives pitocin and foley catheter for initial induction of labor, followed by more pitocin later on.

The registry classes the interventions as drug.

More on the Plan

This randomized controlled trial will include patients with a BMI greater than 30 at the time of admission for their induction of labor.

Patients will be randomized to either misoprostol or Pitocin to begin induction of labor, alongside the standard foley catheter, and the primary outcome of interest will be length of time from start of induction until delivery.

Who Took Part

Enrollment: 303 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

Being open-label, the Oxytocin study did not mask who received what.

It started in 2024-07-02 with completion listed for 2026-08-10.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time from induction to delivery (time frame: start of induction until delivery).

It also tracked 1 secondary outcome, for example Delivery outcome.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 303 people.

The trial is marked completed; 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.