Multicentric Retrospective Study of Perinatal Mortality

Stillbirth Clinical Trial

— PM-PHD-NTM  

Official title:

Clasificación y Factores de Riesgo de la Mortalidad Perinatatal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05491772
• Other study ID #: Perinatal mortality - pHD NTM
• Status: Recruiting
• Start date: August 5, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: Corporacion Parc Tauli
• Contact: Nuria Torre, MD
• Phone: 937231010
• Email: ntorre[@]tauli.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 468
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• ICD
• Morbidity;Perinatal
• Perinatal Morbidity
• Stillbirth

Locations

Country	Name	City	State
Spain	CorporacionPT	Sabadell	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Hospital Clínic Sede Maternitat, Hospital Sant Joan de Deu

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Torre Monmany N, Astete JA, Ramaiah D, Suchitra J, Krauel X, Fillol M, Balasubbaiah Y, Alarcón 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. [Epub ahead of print] — View Citation

Outcome

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