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Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery
Plain-language guide to NCT03006380: phase 2 randomized trial of Oxytocin, 400 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03006380
- Phase
- phase 2
- Status
- status unknown
- Start
- 2016-08
- Completion (planned or actual)
- 2017-08
- Participants
- 400 (estimated)
- Design
- randomized, double-blind, prevention
- Conditions studied
- Postpartum Hemorrhage
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Oxytocin.
It had two arms (groups): oxytocin before placental delivery (experimental) and oxytocin after placental delivery (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 400 planned participants were the target.
It was open to women only aged from 18 years up to 35 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Multiparous women (had previous one, up to four deliveries). Term pregnancy (37 completed weeks at least). Singleton viable cephalic pregnancy.
The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: primigravida.(first pregnancy); grand multiparous. (had previous 5 or more deliveries); maternal illness (involving pregnancy induced condition; pih,gdm or chronic medical condition; hypertension, cardiac , renal problems).
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.
The Oxytocin group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.
Those kept unaware of assignments: participant and outcomes assessor.
It started in 2016-08 with completion listed for 2017-08.
It ran at 1 site in Egypt.
Its stated primary purpose is prevention.
What Was Measured
Researchers chose this as the main measure: blood loss in vaginal delivery (time frame: blood loss in the third stage of labor (Up to 60 min after delivery of the baby)).
It also tracked 10 secondary outcomes, for example primary postpartum hemorrhage, changes in hemoglobin and hematocrit, retained placenta, length of 3rd stage of labor, manual removal of the placenta and blood pressure.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Oxytocin in 400 people.
Its status is unknown; 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.