Clinical trial NCT05491772: Multicentric Retrospective Study of Perinatal Mortality
Official title: Clasificación y Factores de Riesgo de la Mortalidad Perinatatal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perinatal Morbidity
Morbidity;Perinatal
Stillbirth
ICD
Keywords: perinatal mortality
ICD
Perinatal death
stillbirth
neonatal mortality
cause of death
risk factors
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Hospital Sant Joan de Deu
name: Hospital Clínic Sede Maternitat
First posted: 2022-08-08
Enrollment: 468
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Perinatal

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.


Eligibility criteria: 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

Primary outcomes:
measure: International Classification of Disease (10th Revision)- Perinatal Mortalitymaternal condition group
timeFrame: through study completion, an average of 1 year
measure: International Classification of Disease (10th Revision)- Perinatal Mortality cause of death
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Obstetric history
timeFrame: through study completion, an average of 1 year
measure: Mother's age
timeFrame: through study completion, an average of 1 year
measure: Type of pregnancy
timeFrame: through study completion, an average of 1 year
measure: Antenatal care number of visits
timeFrame: through study completion, an average of 1 year
measure: Malaria profilaxis
timeFrame: through study completion, an average of 1 year
measure: HIV status
timeFrame: through study completion, an average of 1 year
measure: Syphilis test
timeFrame: through study completion, an average of 1 year
measure: Mother's LMP
timeFrame: through study completion, an average of 1 year
measure: Date of birth
timeFrame: through study completion, an average of 1 year
measure: Gestational age
timeFrame: through study completion, an average of 1 year
measure: Place of delivery
timeFrame: through study completion, an average of 1 year
measure: Onset of labour
timeFrame: through study completion, an average of 1 year
measure: Fetal heart sounds on admission
timeFrame: through study completion, an average of 1 year
measure: Partograph used
timeFrame: through study completion, an average of 1 year
measure: Mode of delivery
timeFrame: through study completion, an average of 1 year
measure: Time between decision for action and birth
timeFrame: through study completion, an average of 1 year
measure: Apgar Score
timeFrame: through study completion, an average of 1 year
measure: Resuscitation
timeFrame: through study completion, an average of 1 year
measure: Sex of baby
timeFrame: through study completion, an average of 1 year
measure: Birth weight
timeFrame: through study completion, an average of 1 year
measure: Date of death
timeFrame: through study completion, an average of 1 year
measure: Type of death
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: CorporacionPT
state: Barcelona
Study officials:
References:
citation: 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.