Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination (ANDDROID)

October 3, 2017 updated by: University Hospital, Bordeaux

Effect of Intra-venous Oxytocin Injection After Fetal Expulsion in Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination

Prospective randomized trail which compare 2 regimens for third-stage management after second trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional medication after fetal expulsion. Primary outcome was the incidence of placental retention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Complication of third stage of labor in second trimester medical pregnancy termination is not well studied. Accord to publications, the placental retention rate is 30 to 40% in these situations. Placental retention may be associated with increased blood loss, increased requirement for blood transfusion anesthetic and operative complications, and infectious morbidity. The high incidence of retained placenta is an area of clinical concern. Publications reveal a wide variation in practices but there are only few studies about third stage of labor in second trimester medical pregnancy termination. The study is a prospective randomized trial. Two third stage management strategies are compared: 10 units of intra venous oxytocin (group 1) and no additional medication (group 2) after fetal expulsion. It concerns pregnancies between 14 and 28 weeks gestation.

Study Type

Interventional

Enrollment (Anticipated)

27

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 Locations

  • France
      • Bordeaux, France, 33076
        • CHU de Bordeaux

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 years old and older
  • medical pregnancy termination between 14 and 28 weeks gestation
  • informed consent obtained

Exclusion Criteria:

  • less than 18 years old
  • refusal to consent
  • in utero fetal death

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytocin administration after fetal expulsion
Administration of 10 units of intra venous oxytocin after fetal expulsion
Drug: Administration of 10 units of intra venous oxytocin after fetal expulsion
No Intervention: No additional medication after fetal expulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of placental retention
Time Frame: Up to 30 minutes after fetal expulsion
Up to 30 minutes after fetal expulsion

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of partial placental retention
Time Frame: Up to 1 hour after fetal expulsion
Up to 1 hour after fetal expulsion
Incidence of digital exploration
Time Frame: Up to 1 hour after fetal expulsion
Up to 1 hour after fetal expulsion
Incidence of blunt curettage
Time Frame: Up to 1 hour after fetal expulsion
Up to 1 hour after fetal expulsion
Incidence of post-partum hemorrhage
Time Frame: Up to 1 hour after fetal expulsion
Up to 1 hour after fetal expulsion
Blood loss
Time Frame: Up to 1 hour after fetal expulsion
Up to 1 hour after fetal expulsion

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

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)

October 20, 2016

Primary Completion (Actual)

August 4, 2017

Study Completion (Actual)

August 4, 2017

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 18, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2016/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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