In-utero Death and Birth Mortality in Reunion Island

NCT ID: NCT03354832

Last Updated: 2019-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-14

Study Completion Date

2018-09-01

Brief Summary

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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

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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

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Pregnancy Loss Infant Death

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Foetal death

Intervention Type OTHER

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

New-born death

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

New-born death

Intervention Type OTHER

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

Birth control for foetal death

Same gender child born, and alive, in the same hospital, and born on time (37-41 amenorrhea weeks old).

Birth control for foetal death

Intervention Type OTHER

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

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

Birth control for new-born death

Intervention Type OTHER

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

Interventions

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Foetal death

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

Intervention Type OTHER

New-born death

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

Intervention Type OTHER

Birth control for foetal death

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

Intervention Type OTHER

Birth control for new-born death

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

Intervention Type OTHER

Eligibility Criteria

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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

* medical abortion
* second pregnancy during the study period
* case under forensic expertise
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Bernard GOUYON, Pr

Role: PRINCIPAL_INVESTIGATOR

Centre Hpospitalier Universitaire de La REUNION

Locations

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Chu Reunion Island

Saint-Pierre, , Reunion

Site Status

Countries

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Reunion

Other Identifiers

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2016/CHU/08

Identifier Type: -

Identifier Source: org_study_id

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