Perinatal MorbidityPM-PHD-NTMNCT05491772
Multicentric Retrospective Study of Perinatal Mortality
An observational study of Perinatal Morbidity and Morbidity;Perinatal, run by Corporacion Parc Tauli at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Perinatal Morbidity, Morbidity;Perinatal, Stillbirth
- How many people
- 468 participants
- Where
- 1 siteSpain
- Study dates
- 5 Aug 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Perinatal
Who may be able to join
- stillbirths more than 22 weeks of gestation
- neonatal deaths up to 28 days of life
Who cannot join
- avortions more than 22 weeks of gestation
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
CorporacionPT
Sabadell, Barcelona, 08208
Nuria Torre, MD, 937231010, ntorre@tauli.cat
About this study
Official title: 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.
- Conditions
- Perinatal Morbidity, Morbidity;Perinatal, Stillbirth, ICD
- Keywords
- perinatal mortality, ICD, Perinatal death, stillbirth, neonatal mortality, cause of death, risk factors
- Medical subject headings
- Stillbirth, Perinatal Death
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (22)
Obstetric history
number of pregnancies, number of total live births, number of deceased babies, number of stillbirths, number of neonatal deaths, number of abortions
Measured: through study completion, an average of 1 year
Mother's age
age
Measured: through study completion, an average of 1 year
Type of pregnancy
singleton, twins
Measured: through study completion, an average of 1 year
Antenatal care number of visits
number
Measured: through study completion, an average of 1 year
Malaria profilaxis
yes, no
Measured: through study completion, an average of 1 year
HIV status
positive, negative
Measured: through study completion, an average of 1 year
Syphilis test
positive, negative
Measured: through study completion, an average of 1 year
Mother's LMP
date of the last menstrual period
Measured: through study completion, an average of 1 year
Date of birth
date
Measured: through study completion, an average of 1 year
Gestational age
weeks
Measured: through study completion, an average of 1 year
Place of delivery
facility, home, road, others
Measured: through study completion, an average of 1 year
Onset of labour
spontaneous, induced, cesarean before onset
Measured: through study completion, an average of 1 year
Fetal heart sounds on admission
yes, no
Measured: through study completion, an average of 1 year
Partograph used
yes, no
Measured: through study completion, an average of 1 year
Mode of delivery
vaginal, vaginal assisted, cesarean
Measured: through study completion, an average of 1 year
Time between decision for action and birth
not applicable, < 30 min, 30 - 60 min, > 60 min
Measured: through study completion, an average of 1 year
Apgar Score
Apgar Score (min 0, max 10). Higher scores means better outcome
Measured: through study completion, an average of 1 year
Resuscitation
not necessary, suction, stimulation, ventilation, cardiac compressions, not done
Measured: through study completion, an average of 1 year
Sex of baby
male, female, unknown
Measured: through study completion, an average of 1 year
Birth weight
grams
Measured: through study completion, an average of 1 year
Date of death
Date
Measured: through study completion, an average of 1 year
Type of death
neonatal, intrapartum or antepartum or unknown timing stillbirth
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start5 Aug 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Hospital Clínic Sede Maternitat
- Responsible party
- Principal investigator, Nuria Torre-Monmany, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491772
- Sponsor's protocol ID
- Perinatal mortality - pHD NTM
- Acronym
- PM-PHD-NTM
- Status last verified
- Aug 2022
- First submitted
- 24 Jul 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clasificación y Factores de Riesgo de la Mortalidad Perinatatal
- ClinicalTrials.gov ID
- NCT05491772
- Acronym / sponsor ID
- PM-PHD-NTM / Perinatal mortality - pHD NTM
- Conditions
- Perinatal Morbidity, Morbidity;Perinatal, Stillbirth, ICD
- Keywords
- perinatal mortality, ICD, Perinatal death, stillbirth, neonatal mortality, cause of death, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Hospital Clínic Sede Maternitat
- Study start
- 5 Aug 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Perinatal
Key inclusion criteria (2 listed)
- stillbirths more than 22 weeks of gestation
- neonatal deaths up to 28 days of life
Key exclusion criteria (1 listed)
- avortions more than 22 weeks of gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
International Classification of Disease (10th Revision)- Perinatal Mortalitymaternal condition group
Time frame: through study completion, an average of 1 year
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
International Classification of Disease (10th Revision)- Perinatal Mortality cause of death
Time frame: through study completion, an average of 1 year
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
22 secondary outcomes
Obstetric history
Time frame: through study completion, an average of 1 year
Mother's age
Time frame: through study completion, an average of 1 year
Type of pregnancy
Time frame: through study completion, an average of 1 year
Antenatal care number of visits
Time frame: through study completion, an average of 1 year
Malaria profilaxis
Time frame: through study completion, an average of 1 year
HIV status
Time frame: through study completion, an average of 1 year
Syphilis test
Time frame: through study completion, an average of 1 year
Mother's LMP
Time frame: through study completion, an average of 1 year
Date of birth
Time frame: through study completion, an average of 1 year
Gestational age
Time frame: through study completion, an average of 1 year
Place of delivery
Time frame: through study completion, an average of 1 year
Onset of labour
Time frame: through study completion, an average of 1 year
Fetal heart sounds on admission
Time frame: through study completion, an average of 1 year
Partograph used
Time frame: through study completion, an average of 1 year
Mode of delivery
Time frame: through study completion, an average of 1 year
Time between decision for action and birth
Time frame: through study completion, an average of 1 year
Apgar Score
Time frame: through study completion, an average of 1 year
Resuscitation
Time frame: through study completion, an average of 1 year
Sex of baby
Time frame: through study completion, an average of 1 year
Birth weight
Time frame: through study completion, an average of 1 year
Date of death
Time frame: through study completion, an average of 1 year
Type of death
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Background: PubMed 33902133Torre 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Morbidity and Morbidity;Perinatal, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nuria Torre, MD (937231010 ext. 29312, ntorre@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Classification of Disease (10th Revision)- Perinatal Mortalitymaternal condition group (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05491772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.