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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.