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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05491772
Other study ID # Perinatal mortality - pHD NTM
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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