Pregnancy LossRAMIRNCT03354832
In-utero Death and Birth Mortality in Reunion Island
An observational study of Pregnancy Loss and Infant Death, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
Infant mortality is still relevant despite the improvement and the accessibility of hospital care. Premature birth are two fold higher than in metropolitan France. Some factors has been suspected such as precariousness, alcoholism, congenital malformation, care accessibility, epidemic environment ... Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Pregnancy Loss, Infant Death
- What is being tested?
- Foetal death and New-born death
- How many people
- 45 participants
- Where
- 1 siteReunion
- Study dates
- 14 Mar 2017to 1 Sep 2018
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregant women or mother leaving in Reunion Island. Case and control women should have stay during all their pregancy and should have been admitted in an hospital in Reunion Island for delivery.
Who may be able to join
- Case: foetal death (foetus weighing more than 500 g or more than 22-amenorrhea weeks old) or new-born death (premature: more than 23-amenorrhea weeks old or mature)
- Control: premature (more than 23-amenorrhea weeks old) or mature new-born, alive when the leave the hospital
Who cannot join
- medical abortion
- second pregnancy during the study period
- case under forensic expertise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Action on Infant Mortality in Reunion Island Evaluation of Factors Affecting In-utero Foetal Death and New-born Death in Reunion Island
Infant mortality is still relevant despite the improvement and the accessibility of hospital care. Premature birth are two fold higher than in metropolitan France. Some factors has been suspected such as precariousness, alcoholism, congenital malformation, care accessibility, epidemic environment ... Nevertheless, the impact of these factors on foetal death or new-born death are not yet sufficiently quantified to provide appropriate care and prevention action in Reunion Island.
Read the detailed description
Through the analysis of interview of the mothers that have lost their infant during pregnancy or just after birth, the study aims to draw a picture of the pregnancy cares offer and pregnancy conditions in Reunion Island.
This study is an non interventional case-control study. Socio-economic conditions, pregnancy care and prevention are screened to identified the major cause of foetal or new-born death in Reunion Island. These data are still lacking and will be useful to identify which public health actions that should be organized.
- Conditions
- Pregnancy Loss, Infant Death
- Being tested
- Foetal death, New-born death, Birth control for foetal death, Birth control for new-born death
- Medical subject headings
- Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foetal deathOther
A midwife is in charge to interview the mother during the month following the lost of her infant.
New-born deathOther
A midwife is in charge to interview the mother during the month following the lost of her infant.
Birth control for foetal deathOther
A midwife is in charge to interview the mother during her hospital stay
Birth control for new-born deathOther
A midwife is in charge to interview the mother during her hospital stay
| Study group | Role | What they receive |
|---|---|---|
| Foetal death | In-utero dead foetus weighting at least 500 g or 22-amenorrhea weeks old. In utero death means that death occurs during delivery or per partum Receives: Other: Foetal death | |
| New-born death | New-born dead during post-birth hospital stay and at least 23-amenorrhea weeks old. Receives: Other: New-born death | |
| Birth control for foetal death | Same gender child born, and alive, in the same hospital, and born on time (37-41 amenorrhea weeks old). Receives: Other: Birth control for foetal death | |
| Birth control for new-born death | Same gender infant born, and alive, in the same hospital, and:
* for 23-amenorrhea weeks old new-born death: control new-born are born on time (37-41 amenorrhea weeks old).
* for 24 to 31-amenorrhea weeks old new-born death: control new-born are premature infant (24-31 amenorrhea weeks old), and are included when their hospital stay ends.
* for 32 and more-amenorrhea weeks old new-born death: control new-born are 32 and more-amenorrhea weeks old infant Receives: Other: Birth control for new-born death |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of suboptimal care
The main suboptimal care are searched:
- lack or inefficient corticotherapy during pregnancy
- infant birth in an under equipped hospital, without facilities for premature birth
- prenatal diagnosis of serious congenital malformations involving specific care at birth
- lack of B-streptococcus detection
- unexpected caesarean section during delivery
- unexpected dystocia
Measured: within 4 weeks after birth (control) or lost (case)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start14 Mar 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Why it stopped: small number of utero death, mothers refused to participate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy LossStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Bernard GOUYON, Pr, Principal investigator, Centre Hpospitalier Universitaire de La REUNION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354832
- Sponsor's protocol ID
- 2016/CHU/08
- Acronym
- RAMIR
- Status last verified
- Mar 2019
- First submitted
- 22 Nov 2017
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Action on Infant Mortality in Reunion Island Evaluation of Factors Affecting In-utero Foetal Death and New-born Death in Reunion Island
- ClinicalTrials.gov ID
- NCT03354832
- Acronym / sponsor ID
- RAMIR / 2016/CHU/08
- Conditions
- Pregnancy Loss, Infant Death
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: small number of utero death, mothers refused to participate
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 28 Nov 2017 (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.
Infant mortality is still relevant despite the improvement and the accessibility of hospital care. Premature birth are two fold higher than in metropolitan France. Some factors has been suspected such as precariousness, alcoholism, congenital malformation, care accessibility, epidemic environment ... Nevertheless, the impact of these factors on foetal death or new-born death are not yet sufficiently quantified to provide appropriate care and prevention action in Reunion Island.
Detailed description
Through the analysis of interview of the mothers that have lost their infant during pregnancy or just after birth, the study aims to draw a picture of the pregnancy cares offer and pregnancy conditions in Reunion Island.
This study is an non interventional case-control study. Socio-economic conditions, pregnancy care and prevention are screened to identified the major cause of foetal or new-born death in Reunion Island. These data are still lacking and will be useful to identify which public health actions that should be organized.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Foetal death | – | Other: Foetal deathIn-utero dead foetus weighting at least 500 g or 22-amenorrhea weeks old. In utero death means that death occurs during delivery or per partum |
| New-born death | – | Other: New-born deathNew-born dead during post-birth hospital stay and at least 23-amenorrhea weeks old. |
| Birth control for foetal death | – | Other: Birth control for foetal deathSame gender child born, and alive, in the same hospital, and born on time (37-41 amenorrhea weeks old). |
| Birth control for new-born death | – | Other: Birth control for new-born deathSame gender infant born, and alive, in the same hospital, and: * for 23-amenorrhea weeks old new-born death: control new-born are born on time (37-41 amenorrhea weeks old). * for 24 to 31-amenorrhea weeks old new-born death: control new-born are premature infant (24-31 amenorrhea weeks old), and are included when their hospital stay ends. * for 32 and more-amenorrhea weeks old new-born death: control new-born are 32 and more-amenorrhea weeks old infant |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregant women or mother leaving in Reunion Island. Case and control women should have stay during all their pregancy and should have been admitted in an hospital in Reunion Island for delivery.
Key inclusion criteria (2 listed)
- Case: foetal death (foetus weighing more than 500 g or more than 22-amenorrhea weeks old) or new-born death (premature: more than 23-amenorrhea weeks old or mature)
- Control: premature (more than 23-amenorrhea weeks old) or mature new-born, alive when the leave the hospital
Key exclusion criteria (3 listed)
- medical abortion
- second pregnancy during the study period
- case under forensic expertise
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 |
|---|---|---|
| Foetal deathA midwife is in charge to interview the mother during the month following the lost of her infant. | Other | Foetal death |
| New-born deathA midwife is in charge to interview the mother during the month following the lost of her infant. | Other | New-born death |
| Birth control for foetal deathA midwife is in charge to interview the mother during her hospital stay | Other | Birth control for foetal death |
| Birth control for new-born deathA midwife is in charge to interview the mother during her hospital stay | Other | Birth control for new-born death |
Primary outcome
Rate of suboptimal care
Time frame: within 4 weeks after birth (control) or lost (case)
The main suboptimal care are searched: * lack or inefficient corticotherapy during pregnancy * infant birth in an under equipped hospital, without facilities for premature birth * prenatal diagnosis of serious congenital malformations involving specific care at birth * lack of B-streptococcus detection * unexpected caesarean section during delivery * unexpected dystocia
Results and safety
The study was stopped early (reason given: small number of utero death, mothers refused to participate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Jean-Bernard GOUYON, Pr principal investigator
Centre Hpospitalier Universitaire de La REUNION
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 Pregnancy Loss and Infant Death, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 7 Mar 2019. 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 Reunion. 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 was stopped early (reason given: small number of utero death, mothers refused to participate). Results are not available in the source record.
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?
Rate of suboptimal care (time frame: within 4 weeks after birth (control) or lost (case)). 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 7 Mar 2019.