Analysis of All Stillbirths in Stockholm County 2017, a Multidisciplinary Audit

NCT ID: NCT04281368

Last Updated: 2020-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-01-01

Brief Summary

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All stillbirths in Stockholm during 2017 were analysed according to the primary outcomes which were preventable/non-preventable deaths and the level of delay. The secondary outcomes were: causes of death, standard of care pre and post stillbirth and if a summary of the possible causes of death was made as well as the planning of supervision of the next pregnancy.

Detailed Description

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This is a retrospective cohort study. A multidisciplinary team consisting of three obstetricians, one midwife and one neonatologist was assembled. The team represented the largest hospitals in the region-Karolinska University Hospital and Stockholm Soderl Hospital. Each team member in the audit group had access to all the medical patient charts from the hospitals and also the majority of the charts from the antenatal care clinics (ANC). Each team member independently assessed each case regarding causes of death, preventable/non-preventable deaths, the level of delay if there was any and the standard of healthcare provided to the patients with stillbirth, the postmortem examination of infant and mother and if there were any recommendations given for the next pregnancy. Multiple meetings were organized for discussing the results of the individual assessment of each case. To enable an ethical discussion every member of the audit group signed a confidentiality form and all cases were assessed by comparison with local guidelines in praxis.

Conditions

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Intra-Uterine Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Analysis of IUFD

Each team member in the audit group had access to all the medical patient charts from the hospitals and also the majority of the charts from the antenatal care clinics (ANC). Each team member independently assessed each case regarding causes of death, preventable/non-preventable deaths, the level of delay if there was any and the standard of healthcare provided to the patients with stillbirth, the postmortem examination of infant and mother and if there were any recommendations given for the next pregnancy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All stillbirths in Stockholm 2017

Exclusion Criteria

* Missed abortion
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Eva Wiberg-Itzel

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Wiberg-Itzel, PhD

Role: PRINCIPAL_INVESTIGATOR

KI

Locations

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Eva Wiberg-Itzel

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Sterpu I, Bolk J, Perers Oberg S, Hulthen Varli I, Wiberg Itzel E. Could a multidisciplinary regional audit identify avoidable factors and delays that contribute to stillbirths? A retrospective cohort study. BMC Pregnancy Childbirth. 2020 Nov 16;20(1):700. doi: 10.1186/s12884-020-03402-z.

Reference Type DERIVED
PMID: 33198695 (View on PubMed)

Other Identifiers

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IUFD

Identifier Type: -

Identifier Source: org_study_id

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