Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage Management After Second-trimester Abortion: A Randomized Clinical Trial

Ataturk University1 site in 1 country160 target enrollmentJune 8, 2015

ConditionsAbortion, Induced Labor Stage, Third/Drug Effects Pregnancy Trimester, Second Oxytocin/Administration & Dosage

InterventionsOxytocin

Overview

Phase: Phase 4
Intervention: Oxytocin
Conditions: Abortion, Induced
Sponsor: Ataturk University
Enrollment: 160
Locations: 1
Primary Endpoint: Complete abortion rate
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or observation with no pharmacologic intervention. Primary outcome of the study is complete abortion rate within two hours of fetal delivery.

Registry

clinicaltrials.gov

Start Date

June 8, 2015

End Date

June 10, 2016

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ataturk University

Responsible Party

Principal Investigator

Ragıp Atakan Al

professor

Ataturk University

Eligibility Criteria

Inclusion Criteria

•Women who had mid-trimester termination of pregnancy between 13-24 gestational weeks

Exclusion Criteria

•If fetus and placenta expelled together
•Obstetrical haemorrhage needs intervention
•Known prostaglandin allergy

Arms & Interventions

Oxytocin

Intervention: Oxytocin

Outcomes

Primary Outcomes

Complete abortion rate

Time Frame: within 5 minute after placenta delivered

expulsion of placenta completely without an instrumental assistance within two hours after delivery of fetus

Secondary Outcomes

Blood loss estimated by gravimetric method(within 10 minutes after delivery of placenta)
Transfusion rate(Within 7 days of hospitalization)
Change in hemoglobin measured by difference in hemoglobin before and 24-hour after abortion(24 hours after delivery of placenta)
Placenta delivery time measured by time elapsed until the delivery of the placenta from the delivery of foetus(5 minute after delivery of placenta)