Multicentric Retrospective Study of Perinatal Mortality

Recruiting

• Conditions: Stillbirth; ICD; Morbidity;Perinatal; Perinatal Morbidity

• Registration Number: NCT05491772
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

Background: Perinatal mortality ranges mortality from 22 gestational weeks up to the first 7 days of life and extended mortality goes up to 28 days of life. The perinatal mortality rate is the most sensitive index of the health status of women and their offspring and of the quality of maternal and child health services. Per our knowledge, there is no study that evaluates perinatal mortality in Catalonia, although household data are available from each hospital. Moreover, the official records usually do not match with the household surveys due to lack of clarity on the definitions. Aim: the aim of the study is to compare the WHO perinatal mortality classification following the ICD-PM in comparison with the used classification. Methodology: Multicentric retrospective study. Data from Sant Joan de Déu, Maternitat Clinic and Parc Taulí hospitals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-24
• Status Verified: 2022-08
• Study Start: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Last Update Submitted: 2022-08-05
• Study First Posted: 2022-08-08
• Last Update Posted: 2022-08-08
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 468

Inclusion Criteria

• stillbirths more than 22 weeks of gestation
• neonatal deaths up to 28 days of life

Exclusion Criteria

• avortions more than 22 weeks of gestation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Classification of Disease (10th Revision)- Perinatal Mortalitymaternal condition group	through study completion, an average of 1 year	The ICD-PM provides a standardised system for classifying perinatal mortality (including stillbirths) based on time of death (antepartum or intrapartum) into fetal and maternal causes thereby enabling comparisons within and between diverse settings and contexts
International Classification of Disease (10th Revision)- Perinatal Mortality cause of death	through study completion, an average of 1 year	The ICD-PM provides a standardised system for classifying perinatal mortality (including stillbirths) based on time of death (antepartum or intrapartum) into fetal and maternal causes thereby enabling comparisons within and between diverse settings and contexts

Secondary Outcome Measures

Name	Time	Method
Obstetric history	through study completion, an average of 1 year	number of pregnancies, number of total live births, number of deceased babies, number of stillbirths, number of neonatal deaths, number of abortions
HIV status	through study completion, an average of 1 year	positive, negative
Partograph used	through study completion, an average of 1 year	yes, no
Malaria profilaxis	through study completion, an average of 1 year	yes, no
Date of birth	through study completion, an average of 1 year	date
Type of pregnancy	through study completion, an average of 1 year	singleton, twins
Syphilis test	through study completion, an average of 1 year	positive, negative
Fetal heart sounds on admission	through study completion, an average of 1 year	yes, no
Sex of baby	through study completion, an average of 1 year	male, female, unknown
Date of death	through study completion, an average of 1 year	Date
Type of death	through study completion, an average of 1 year	neonatal, intrapartum or antepartum or unknown timing stillbirth
Onset of labour	through study completion, an average of 1 year	spontaneous, induced, cesarean before onset
Mode of delivery	through study completion, an average of 1 year	vaginal, vaginal assisted, cesarean
Time between decision for action and birth	through study completion, an average of 1 year	not applicable, \< 30 min, 30 - 60 min, \> 60 min
Apgar Score	through study completion, an average of 1 year	Apgar Score (min 0, max 10). Higher scores means better outcome
Mother's age	through study completion, an average of 1 year	age
Antenatal care number of visits	through study completion, an average of 1 year	number
Mother's LMP	through study completion, an average of 1 year	date of the last menstrual period
Gestational age	through study completion, an average of 1 year	weeks
Place of delivery	through study completion, an average of 1 year	facility, home, road, others
Resuscitation	through study completion, an average of 1 year	not necessary, suction, stimulation, ventilation, cardiac compressions, not done
Birth weight	through study completion, an average of 1 year	grams

Trial Locations

Locations (1)

CorporacionPT; 🇪🇸 Sabadell, Barcelona, Spain