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

Primary Purpose

Retained Placenta

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Administration of 10 units of intra venous oxytocin after fetal expulsion
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Retained Placenta focused on measuring Retained Placenta, Second trimester medical termination, Third stage labor, Oxytocin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oxytocin administration after fetal expulsion

No additional medication after fetal expulsion

Arm Description

Administration of 10 units of intra venous oxytocin after fetal expulsion

Outcomes

Primary Outcome Measures

Incidence of placental retention

Secondary Outcome Measures

Incidence of partial placental retention
Incidence of digital exploration
Incidence of blunt curettage
Incidence of post-partum hemorrhage
Blood loss

Full Information

First Posted
November 17, 2016
Last Updated
October 3, 2017
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02969447
Brief Title
Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination
Acronym
ANDDROID
Official Title
Effect of Intra-venous Oxytocin Injection After Fetal Expulsion in Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 20, 2016 (Actual)
Primary Completion Date
August 4, 2017 (Actual)
Study Completion Date
August 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retained Placenta
Keywords
Retained Placenta, Second trimester medical termination, Third stage labor, Oxytocin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin administration after fetal expulsion
Arm Type
Experimental
Arm Description
Administration of 10 units of intra venous oxytocin after fetal expulsion
Arm Title
No additional medication after fetal expulsion
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Administration of 10 units of intra venous oxytocin after fetal expulsion
Primary Outcome Measure Information:
Title
Incidence of placental retention
Time Frame
Up to 30 minutes after fetal expulsion
Secondary Outcome Measure Information:
Title
Incidence of partial placental retention
Time Frame
Up to 1 hour after fetal expulsion
Title
Incidence of digital exploration
Time Frame
Up to 1 hour after fetal expulsion
Title
Incidence of blunt curettage
Time Frame
Up to 1 hour after fetal expulsion
Title
Incidence of post-partum hemorrhage
Time Frame
Up to 1 hour after fetal expulsion
Title
Blood loss
Time Frame
Up to 1 hour after fetal expulsion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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