NCT03393455

Brief Summary

More and more parents decide to maintain pregnancy which could have been interrupted because of serious fetal pathologies. In this observational study, the investigators examine obstetrical and pediatric evolution of these pregnancies, from 2006 to 2016 in Montpellier University Hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
Last Updated

July 19, 2018

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

October 12, 2017

Last Update Submit

July 17, 2018

Conditions

Termination of Pregnancy

Keywords

Fetal pathologyObstetrical outcomePediatric outcome

Outcome Measures

Primary Outcomes (1)

  • Apgar score at 5 minutes

    Apgar score at 5 minutes

    1 day

Secondary Outcomes (1)

  • health status of children

    1 day

Interventions

not accurateOTHER

not accurate

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Mother and child after refusal of termination of pregnancy despite serious fetal pathology

You may qualify if:

  • \- refusal of termination of pregnancy despite serious fetal pathology

You may not qualify if:

  • termination of pregnancy
  • termination of pregnancy not accepted by the Interdisciplinary Center for Prenatal Diagnostics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

  • florent FUCHS

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2017

First Posted

January 8, 2018

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 31, 2016

Last Updated

July 19, 2018

Record last verified: 2017-10

Locations

FR(1)