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Intramuscular Versus Intravenous Prophylactic Oxytocin for Hemorrhage After Vaginal Delivery

Plain-language guide to NCT02080104: not phased randomized trial of Oxytocin, 2 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02080104
Phase
not phased
Status
status unknown
Start
2014-02
Completion (planned or actual)
2015-02
Participants
2 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Postpartum Hemorrhage
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

Intramuscular versus intravenous prophylactic oxytocin for the third stage of labour following vaginal delivery: A randomised controlled trial.

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

Group which 2 ampul prophylactic oxytocin given for third stage of labour intravenously after vaginal delivery.

Group which oxytocin administered intramusculary after vaginal delivery.

The registry classes the interventions as drug.

More on the Plan

Intramuscular application is faster , easier and tougher enforcement requires less skill and equipment .

For this reason, less educated , which can be applied by those offering health services .

Who Took Part

2 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Research volunteers, the undersigned, pregnant women. Only with vaginal delivery (episiotomy and perineal tears can). \> 34 weeks or more will be. Cephalic presentation will be. At low risk of postpartum hemorrhage.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: \<18 years; multiple pregnancies; the presence of uterine myoma.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2014-02 with completion listed for 2015-02.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: early postpartum hemorrhage (time frame: postpartum 24 hours).

It also tracked 1 secondary outcome, for example Blood transfusion requirement.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 2 people.

Its size is small, so on its own it can only give an early look.

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.