In-utero Death and Birth Mortality in Reunion Island (RAMIR)

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.

Study Overview

• Status: Terminated
• Conditions: Infant Death; Pregnancy Loss
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Réunion
  • Saint-Pierre, Réunion, 97410
    • CHU Reunion Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within 4 weeks after birth (control) or lost (case)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Jean-Bernard GOUYON, Pr, Centre Hpospitalier Universitaire de La REUNION

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2017
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (ACTUAL): November 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Death; Infant Death
• Other Study ID Numbers: 2016/CHU/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No