In-utero Death and Birth Mortality in Reunion Island

NCT03354832 | Terminated

• 1 other identifier: 2016/CHU/08
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Loss; Infant Death

Outcome Measures

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

  within 4 weeks after birth (control) or lost (case)

Study Arms (4)

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

Foetal death OTHER

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

Foetal death

New-born death OTHER

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

New-born death

Birth control for foetal death OTHER

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

Birth control for foetal death

Birth control for new-born death OTHER

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

Birth control for new-born death

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Chu Reunion Island

Saint-Pierre, 97410, Reunion

Location

MeSH Terms

Conditions

Infant Death

Interventions

Contraception

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics

Study Officials

• Jean-Bernard GOUYON, Pr

  Centre Hpospitalier Universitaire de La REUNION

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: March 14, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)