Multicentric Retrospective Study of Perinatal Mortality

NCT05491772 | Unknown

• 1 other identifier: Perinatal mortality - pHD NTM
• Study Type: observational
• Target: 468
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Morbidity; Morbidity;Perinatal; Stillbirth; ICD

Keywords

perinatal mortality; ICD; Perinatal death; stillbirth; neonatal mortality; cause of death; risk factors

Outcome Measures

Primary Outcomes (2)

• International Classification of Disease (10th Revision)- Perinatal Mortalitymaternal condition group

  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

  through study completion, an average of 1 year

• International Classification of Disease (10th Revision)- Perinatal Mortality cause of death

  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

  through study completion, an average of 1 year

Secondary Outcomes (22)

• Obstetric history

  through study completion, an average of 1 year

• Mother's age

  through study completion, an average of 1 year

• Type of pregnancy

  through study completion, an average of 1 year

• Antenatal care number of visits

  through study completion, an average of 1 year

• Malaria profilaxis

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Perinatal

You may qualify if:

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

You may not qualify if:

• \- avortions more than 22 weeks of gestation

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Hospital Sant Joan de Deu: collaborator
• Hospital Clínic Sede Maternitat: collaborator

Study Sites (1)

CorporacionPT

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Publications (1)

• Torre Monmany N, Astete JA, Ramaiah D, Suchitra J, Krauel X, Fillol M, Balasubbaiah Y, Alarcon A, Bassat Q. Extended Perinatal Mortality Audit in a Rural Hospital in India. Am J Perinatol. 2023 Mar;40(4):375-386. doi: 10.1055/s-0041-1727220. Epub 2021 Apr 26.

  PMID: 33902133 BACKGROUND

MeSH Terms

Conditions

Stillbirth; Perinatal Death

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nuria Torre, MD

CONTACT

937231010; ntorre@tauli.cat

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: August 8, 2022
• Study Start: August 5, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

ES (1)