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Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful?

Plain-language guide to NCT00540748: not phased randomized trial of Oxytocin, 400 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00540748
Phase
not phased
Status
completed
Start
2007-10
Completion (planned or actual)
2009-06
Participants
400 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Induced Abortion
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Oxytocin.

Comparison is done between the two groups measuring the following outcomes: pain, nausea and blood loss.

It had two arms (groups): A1 (experimental) and A2 (no intervention).

The registry classes the interventions as drug.

More on the Plan

All women seeking surgical abortion before 12 weeks of pregnancy will be invited to participate in the study.

The researchers will include 400 patients.

Pain is measured on a VAS-scale (1-10) 2 hours post operatively and repeated 2 days postoperatively.

The two groups will be compared.

Who Took Part

Enrollment: 400 planned participants were the target.

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

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

Examples of who could join: Seeking legal abortion. No current medication. Fluent in norwegian language.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: current medication; medical condition with coagulopathy.

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2007-10 with completion listed for 2009-06.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: blood loss, pain, nausea (time frame: 2 years).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 400 people.

The trial is marked completed; 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.