- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03393455
Obstetric & Pediatric Evolution Following Parental Refusal for Early Termination of Pregnancy Despite Fetal Risk
July 17, 2018 updated by: University Hospital, Montpellier
Evolution of Maternal & Infantile Health Following Parental Refusal of Termination of Pregnancy Despite Such Option Being Allowable by the Centre Pluridisciplinary de Diagnostic Prenatal (Interdisciplinary Center for Prenatal Diagnostics)
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
211
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- Uhmontpellier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Mother and child after refusal of termination of pregnancy despite serious fetal pathology
Description
Inclusion criteria:
- refusal of termination of pregnancy despite serious fetal pathology
Exclusion criteria:
- termination of pregnancy
- termination of pregnancy not accepted by the Interdisciplinary Center for Prenatal Diagnostics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Apgar score at 5 minutes
Time Frame: 1 day
|
Apgar score at 5 minutes
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
health status of children
Time Frame: 1 day
|
health status of children at 1 year old : alive or dead.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: florent FUCHS, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
October 12, 2017
First Submitted That Met QC Criteria
January 2, 2018
First Posted (Actual)
January 8, 2018
Study Record Updates
Last Update Posted (Actual)
July 19, 2018
Last Update Submitted That Met QC Criteria
July 17, 2018
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- RECHMPL17_0260
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
NC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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