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

Phase 4

Completed

• Conditions: Retained Placenta
• Interventions: Drug: Administration of 10 units of intra venous oxytocin after fetal expulsion

• Registration Number: NCT02969447
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

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 Timeline

• Study Start: 2016-10-20
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-21
• Primary Completion: 2017-08-04
• Study Completion: 2017-08-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin administration after fetal expulsion	Administration of 10 units of intra venous oxytocin after fetal expulsion	Administration of 10 units of intra venous oxytocin after fetal expulsion

Primary Outcome Measures

Name	Time	Method
Incidence of placental retention	Up to 30 minutes after fetal expulsion

Secondary Outcome Measures

Name	Time	Method
Incidence of partial placental retention	Up to 1 hour after fetal expulsion
Incidence of digital exploration	Up to 1 hour after fetal expulsion
Incidence of blunt curettage	Up to 1 hour after fetal expulsion
Incidence of post-partum hemorrhage	Up to 1 hour after fetal expulsion
Blood loss	Up to 1 hour after fetal expulsion

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France