RAMIR: In-utero Death and Birth Mortality in Reunion Island

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Terminated
CT.gov ID
NCT03354832
Collaborator
(none)
45
1
17.6
2.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Foetal death
  • Other: New-born death
  • Other: Birth control for foetal death
  • Other: Birth control for new-born death

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

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Actual Study Start Date :
Mar 14, 2017
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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
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.

Other: New-born death
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).

Other: Birth control for foetal death
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

Other: Birth control for new-born death
A midwife is in charge to interview the mother during her hospital stay

Outcome Measures

Primary Outcome Measures

  1. Rate of suboptimal care [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Reunion Island Saint-Pierre Réunion 97410

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de la Réunion

Investigators

  • Principal Investigator: Jean-Bernard GOUYON, Pr, Centre Hpospitalier Universitaire de La REUNION

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT03354832
Other Study ID Numbers:
  • 2016/CHU/08
First Posted:
Nov 28, 2017
Last Update Posted:
Mar 7, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2019