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Status unknownNCT05491772PM-PHD-NTMUpdated Aug 8, 2022

Multicentric Retrospective Study of Perinatal Mortality

An observational study in Perinatal Morbidity, Morbidity;Perinatal and Stillbirth, sponsored by Corporacion Parc Tauli. Status unknown at 1 site in Spain. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2022-08-08.

Sponsored by Corporacion Parc Tauli · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
468
Ages
0 Days to 28 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Perinatal Morbidity
  • Morbidity;Perinatal
  • Stillbirth
  • ICD

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Keywords

  • perinatal mortality
  • ICD
  • Perinatal death
  • stillbirth
  • neonatal mortality
  • cause of death
  • risk factors
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In context

Stillbirth

117 studies on the registry are indexed under Stillbirth; 33 are open to participants now.

This study's planned enrollment of 468 is below the median of 794 across 50 observational studies indexed under Stillbirth.

Browse Stillbirth studies →

Lead sponsor

Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Perinatal

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • avortions more than 22 weeks of gestation
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
468 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: through study completion, an average of 1 year

  2. 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

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Obstetric history

    number of pregnancies, number of total live births, number of deceased babies, number of stillbirths, number of neonatal deaths, number of abortions

    Time frame: through study completion, an average of 1 year

  2. Mother's age

    age

    Time frame: through study completion, an average of 1 year

  3. Type of pregnancy

    singleton, twins

    Time frame: through study completion, an average of 1 year

  4. Antenatal care number of visits

    number

    Time frame: through study completion, an average of 1 year

  5. Malaria profilaxis

    yes, no

    Time frame: through study completion, an average of 1 year

  6. HIV status

    positive, negative

    Time frame: through study completion, an average of 1 year

  7. Syphilis test

    positive, negative

    Time frame: through study completion, an average of 1 year

  8. Mother's LMP

    date of the last menstrual period

    Time frame: through study completion, an average of 1 year

  9. Date of birth

    date

    Time frame: through study completion, an average of 1 year

  10. Gestational age

    weeks

    Time frame: through study completion, an average of 1 year

  11. Place of delivery

    facility, home, road, others

    Time frame: through study completion, an average of 1 year

  12. Onset of labour

    spontaneous, induced, cesarean before onset

    Time frame: through study completion, an average of 1 year

  13. Fetal heart sounds on admission

    yes, no

    Time frame: through study completion, an average of 1 year

  14. Partograph used

    yes, no

    Time frame: through study completion, an average of 1 year

  15. Mode of delivery

    vaginal, vaginal assisted, cesarean

    Time frame: through study completion, an average of 1 year

  16. Time between decision for action and birth

    not applicable, \< 30 min, 30 - 60 min, \> 60 min

    Time frame: through study completion, an average of 1 year

  17. Apgar Score

    Apgar Score (min 0, max 10). Higher scores means better outcome

    Time frame: through study completion, an average of 1 year

  18. Resuscitation

    not necessary, suction, stimulation, ventilation, cardiac compressions, not done

    Time frame: through study completion, an average of 1 year

  19. Sex of baby

    male, female, unknown

    Time frame: through study completion, an average of 1 year

  20. Birth weight

    grams

    Time frame: through study completion, an average of 1 year

  21. Date of death

    Date

    Time frame: through study completion, an average of 1 year

  22. Type of death

    neonatal, intrapartum or antepartum or unknown timing stillbirth

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • CorporacionPT
    Sabadell, Barcelona 08208, Spain
    Recruiting
08

References and documents

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. 2023 Mar;40(4):375-386. doi: 10.1055/s-0041-1727220. Epub 2021 Apr 26. PubMed 33902133 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05491772
Lead sponsor
Corporacion Parc Tauli
Collaborators
Hospital Sant Joan de Deu, Hospital Clínic Sede Maternitat
Responsible party
Nuria Torre-Monmany (Principal Investigator, Corporacion Parc Tauli) — Principal investigator
First posted
Aug 8, 2022
Start date
Aug 5, 2022 (estimated)
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Aug 8, 2022

Study contacts

Nuria Torre, MD
Contact
ntorre@tauli.cat
937231010 ext. 29312

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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