Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion

Phase 4

Completed

• Conditions: Labor Stage, Third/Drug Effects; Oxytocin/Administration & Dosage; Abortion, Induced; Pregnancy Trimester, Second
• Interventions: Drug: Oxytocin

• Registration Number: NCT02485444
• Lead Sponsor: Ataturk University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-08
• Study First Submitted: 2015-06-28
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-06-30
• Primary Completion: 2016-05-31
• Study Completion: 2016-06-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-25
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin	Oxytocin	-

Primary Outcome Measures

Name	Time	Method
Complete abortion rate	within 5 minute after placenta delivered	expulsion of placenta completely without an instrumental assistance within two hours after delivery of fetus

Secondary Outcome Measures

Name	Time	Method
Blood loss estimated by gravimetric method	within 10 minutes after delivery of placenta	blood loss will be estimated by gravimetric method
Transfusion rate	Within 7 days of hospitalization	number of packed red cell units transfused
Change in hemoglobin measured by difference in hemoglobin before and 24-hour after abortion	24 hours after delivery of placenta	Difference in hemoglobin before and 24-hour after abortion
Placenta delivery time measured by time elapsed until the delivery of the placenta from the delivery of foetus	5 minute after delivery of placenta	The time elapsed until the delivery of the placenta from the delivery of foetus

Trial Locations

Locations (1)

Atatürk Üniversitesi Araştırma Hastanesi; 🇹🇷 Erzurum, Turkey