PM-PHD-NTM: Multicentric Retrospective Study of Perinatal Mortality

Sponsor

Corporacion Parc Tauli (Other)

Overall Status

Recruiting

CT.gov ID

NCT05491772

Collaborator

Hospital Sant Joan de Deu (Other), Hospital Clínic Sede Maternitat (Other)

468

Enrollment

Location

28.9

Anticipated Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perinatal Morbidity Morbidity;Perinatal Stillbirth ICD

Study Design

Study Type:

Observational

Anticipated Enrollment :

468 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Clasificación y Factores de Riesgo de la Mortalidad Perinatatal

Anticipated Study Start Date :

Aug 5, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

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

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
Mother's age [through study completion, an average of 1 year]
age
Type of pregnancy [through study completion, an average of 1 year]
singleton, twins
Antenatal care number of visits [through study completion, an average of 1 year]
number
Malaria profilaxis [through study completion, an average of 1 year]
yes, no
HIV status [through study completion, an average of 1 year]
positive, negative
Syphilis test [through study completion, an average of 1 year]
positive, negative
Mother's LMP [through study completion, an average of 1 year]
date of the last menstrual period
Date of birth [through study completion, an average of 1 year]
date
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
Onset of labour [through study completion, an average of 1 year]
spontaneous, induced, cesarean before onset
Fetal heart sounds on admission [through study completion, an average of 1 year]
yes, no
Partograph used [through study completion, an average of 1 year]
yes, no
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
Resuscitation [through study completion, an average of 1 year]
not necessary, suction, stimulation, ventilation, cardiac compressions, not done
Sex of baby [through study completion, an average of 1 year]
male, female, unknown
Birth weight [through study completion, an average of 1 year]
grams
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