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Calcium Carbonate to Augment Labor Contractions

Plain-language guide to NCT06580782: phase 4 randomized trial of Oxytocin, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06580782
Phase
phase 4
Status
recruiting participants
Start
2024-11-18
Completion (planned or actual)
2025-12
Participants
60 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Labor Dystocia; Labor Induction; Labor Augmentation
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin.

It had two arms (groups): Pitocin (active comparator) and Calcium Carbonate with Pitocin (experimental).

Participants will start an oral calcium carbonate regimen at the same time as initiating synthetic oxytocin (Pitocin) infusion.

The registry classes the interventions as drug.

More on the Plan

This study plans to study the acceptance and safety of using calcium carbonate as an medicine to help the labor induction process.

Who Took Part

The registry lists 60 planned participants were the target.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 18 years or older. Nulliparas (no prior pregnancy lasting 20 weeks or greater of gestation). Gestational age above 36 weeks, at enrollment. Ability to give informed consent. Planned to undergo initiation of oxytocin infusion by their maternity care provider.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: unable to understand or read english; non-vertex presenting fetus at enrollment; planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, previous transmural myomectomy).

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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.

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

Only one side, usually the participants, was kept unaware of whether Oxytocin was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2024-11-18 with completion listed for 2025-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants Consented (time frame: Day 0). Number of Participants Enrolled (time frame: Day 0). Number of Participants that complete the Intervention as prescribed (Adherence) (time frame: During hospitalization, approximately 5 days).

It also tracked 10 secondary outcomes, for example Duration of Labor (minutes), Mode of Delivery, Number of Postpartum Hemorrhages, Number of Treatment Related Adverse Events, Neonatal health (APGAR Score) and Neonatal health (Cord Blood Gases).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 60 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.