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Comparing High Versus Low Dose of Oxytocin, in Gravida Women With BMI 30 and Above Which Are Undergoing Induction of Labor

Plain-language guide to NCT06990217: phase 4 randomized trial of Oxytocin, 130 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06990217
Phase
phase 4
Status
not yet recruiting
Start
2025-06
Completion (planned or actual)
2027-06
Participants
130 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Induction of Labor; Augmentation of Labor
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Oxytocin.

It had two arms (groups): one (active comparator) and one (other).

The registry classes the interventions as drug.

More on the Plan

Women at term (37-42 weeks), requiring the use of oxytocin for induction of labor or for augmentation of labor.

Who are obese (BMI 30 and above), Viable singleton pregnancies with Cephalic presentation.

After their consent, will be randomization: in a 1:1 allocation.

The primary outcome of the study is the time from the start of oxytocin to delivery Statistical analysis Mean time interval from initiation of augmentation/ induction with oxytocin until delivery was eight hours (±240 minutes), based on previous observation at the delivery ward.

Who Took Part

130 planned participants were the target.

It was open to women only.

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

Examples of who could join: Women at term (37-42 weeks), requiring the use of oxytocin for induction of labor or for augmentation of labor. BMI 30 and above. Viable singleton pregnancies. No contraindication for vaginal delivery.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: women with previous cesarean delivery; multiple pregnancy; multiple fetal malformations.

How the Study Was Run

The set-up was 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.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-06 with completion listed for 2027-06.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time from the start of oxytocin to delivery (time frame: from the start of induction till delivery).

It also tracked 14 secondary outcomes, for example Maternal age, mode of delivery, intrapartum fever, uterine rupture, perineal tears and PPH.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 130 people.

Its status is not yet 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.