NCT02969447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2017

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

November 17, 2016

Last Update Submit

October 3, 2017

Conditions

Retained Placenta

Keywords

Retained PlacentaSecond trimester medical terminationThird stage laborOxytocin

Outcome Measures

Primary Outcomes (1)

  • Incidence of placental retention

    Up to 30 minutes after fetal expulsion

Secondary Outcomes (5)

  • 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

Study Arms (2)

Oxytocin administration after fetal expulsion

EXPERIMENTAL

Administration of 10 units of intra venous oxytocin after fetal expulsion

Drug: Administration of 10 units of intra venous oxytocin after fetal expulsion

No additional medication after fetal expulsion

NO INTERVENTION

Interventions

Administration of 10 units of intra venous oxytocin after fetal expulsionDRUG
Oxytocin administration after fetal expulsion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Placenta, Retained

Condition Hierarchy (Ancestors)

Placenta DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 21, 2016

Study Start

October 20, 2016

Primary Completion

August 4, 2017

Study Completion

August 4, 2017

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations

FR(1)