Termination of PregnancyNCT03393455
Obstetric & Pediatric Evolution Following Parental Refusal for Early Termination of Pregnancy Despite Fetal Risk
An observational study of Termination of Pregnancy, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Termination of Pregnancy
- What is being tested?
- not accurate
- How many people
- 211 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mother and child after refusal of termination of pregnancy despite serious fetal pathology
Who may be able to join
- refusal of termination of pregnancy despite serious fetal pathology
Who cannot join
- termination of pregnancy
- termination of pregnancy not accepted by the Interdisciplinary Center for Prenatal Diagnostics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Termination of Pregnancy
- Being tested
- not accurate
- Keywords
- Fetal pathology, Obstetrical outcome, Pediatric outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not accurateOther
not accurate
What is being measured
The primary outcome is the main question the study is designed to answer.
Apgar score at 5 minutes
Apgar score at 5 minutes
Measured: 1 day
Secondary outcomes (1)
health status of children
health status of children at 1 year old : alive or dead.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Jan 2016
- Primary completion1 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Termination of PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- florent FUCHS, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393455
- Sponsor's protocol ID
- RECHMPL17_0260
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03393455
- Acronym / sponsor ID
- RECHMPL17_0260
- Conditions
- Termination of Pregnancy
- Keywords
- Fetal pathology, Obstetrical outcome, Pediatric outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mother and child after refusal of termination of pregnancy despite serious fetal pathology
Key inclusion criteria (1 listed)
- refusal of termination of pregnancy despite serious fetal pathology
Key exclusion criteria (2 listed)
- termination of pregnancy
- termination of pregnancy not accepted by the Interdisciplinary Center for Prenatal Diagnostics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not accuratenot accurate | Other | – |
Primary outcome
Apgar score at 5 minutes
Time frame: 1 day
Apgar score at 5 minutes
1 secondary outcome
health status of children
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
florent FUCHS principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Termination of Pregnancy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apgar score at 5 minutes (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.