In-utero Death and Birth Mortality in Reunion Island

Pregnancy Loss Clinical Trial

— RAMIR  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03354832
• Other study ID #: 2016/CHU/08
• Status: Terminated
• Start date: March 14, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Infant Death
• Pregnancy Loss

Intervention

Other:
• Foetal death
A midwife is in charge to interview the mother during the month following the lost of her infant.
• 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
A midwife is in charge to interview the mother during her hospital stay
• Birth control for new-born death
A midwife is in charge to interview the mother during her hospital stay

Locations

Country	Name	City	State
Réunion	Chu Reunion Island	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)