Multicentric Retrospective Study of Perinatal Mortality (PM-PHD-NTM)

Clasificación y Factores de Riesgo de la Mortalidad Perinatatal

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 468

Contacts and Locations

• Study Contact: Name: Nuria Torre, MD; Phone Number: 29312 937231010; Email: ntorre@tauli.cat

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • CorporacionPT
      • Contact: Nuria Torre, MD; Phone Number: 937231010; Email: ntorre@tauli.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Perinatal

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Hospital Sant Joan de Deu; Hospital Clínic Sede Maternitat

Publications and helpful links

General Publications

• 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. 2021 Apr 26. doi: 10.1055/s-0041-1727220. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 5, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 24, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: risk factors; ICD; perinatal mortality; neonatal mortality; Perinatal death; cause of death; stillbirth
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Stillbirth
• Other Study ID Numbers: Perinatal mortality - pHD NTM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No