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

NCT ID: NCT02969447

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-20

Study Completion Date

2017-08-04

Brief Summary

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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

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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.

Conditions

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Retained Placenta

Keywords

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Retained Placenta Second trimester medical termination Third stage labor Oxytocin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oxytocin administration after fetal expulsion

Administration of 10 units of intra venous oxytocin after fetal expulsion

Group Type EXPERIMENTAL

Administration of 10 units of intra venous oxytocin after fetal expulsion

Intervention Type DRUG

No additional medication after fetal expulsion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Administration of 10 units of intra venous oxytocin after fetal expulsion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2016/20

Identifier Type: -

Identifier Source: org_study_id