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

February 25, 2023 updated by: Ragıp Atakan Al, Atatürk University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Erzurum, Turkey, 25240
        • Atatürk Üniversitesi Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observation
Active Comparator: Oxytocin
Drug: Oxytocin
20 IU oxytocin in 500 ml normal saline will be infused 100 ml/h i.v. after fetus is delivered
Other Names:
  • Pitocin
  • Synpitan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 5 minute after placenta delivered

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atatürk University

Investigators

  • Study Chair: Omer E Yapca, MD, Ataturk University
  • Principal Investigator: Ragıp A AL, MD, Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2015

Primary Completion (Actual)

May 31, 2016

Study Completion (Actual)

June 10, 2016

Study Registration Dates

First Submitted

June 28, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 25, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-80

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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