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TerminatedNCT03354832RAMIRUpdated Mar 7, 2019

In-utero Death and Birth Mortality in Reunion Island

An observational study in Pregnancy Loss and Infant Death, sponsored by Centre Hospitalier Universitaire de la Réunion. Terminated at 1 site in Réunion. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-03-07.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Observational

Why this study was terminated
small number of utero death, mothers refused to participate
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
45
Ages
16 Years and older
Sex
Female
01

Study 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 ... 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.

02

Conditions studied

  • Pregnancy Loss
  • Infant Death

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03

In context

Infant Death

51 studies on the registry are indexed under Infant Death; 15 are open to participants now.

This study's enrollment of 45 is below the median of 368 across 11 observational studies indexed under Infant Death.

Browse Infant Death studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • medical abortion
  • second pregnancy during the study period
  • case under forensic expertise
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Other: Foetal death

  • New-born death

    New-born dead during post-birth hospital stay and at least 23-amenorrhea weeks old.

    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).

    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

    Other: Birth control for new-born death

Interventions

  • OtherFoetal death

    A midwife is in charge to interview the mother during the month following the lost of her infant.

  • OtherNew-born death

    A midwife is in charge to interview the mother during the month following the lost of her infant.

  • OtherBirth control for foetal death

    A midwife is in charge to interview the mother during her hospital stay

  • OtherBirth control for new-born death

    A midwife is in charge to interview the mother during her hospital stay

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What researchers measure

Primary outcomes

  1. 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

    Time frame: within 4 weeks after birth (control) or lost (case)

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Study locations

1 site
  • Chu Reunion Island
    Saint-Pierre, 97410, Réunion
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2017 to primary completion in Sep 2018, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2017
First posted
Nov 28, 2017
StartActual
Mar 14, 2017
Primary completionActual
Sep 1, 2018
CompletionActual
Sep 1, 2018
Last update
Mar 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03354832
Responsible party
Sponsor
First posted
Nov 28, 2017
Start date
Mar 14, 2017
Primary completion
Sep 1, 2018
Completion
Sep 1, 2018
Last update
Mar 7, 2019

Study contacts

Jean-Bernard GOUYON, Pr
principal investigator · Centre Hpospitalier Universitaire de La REUNION

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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