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

Intra-Uterine Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281368
• Other study ID #: IUFD
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• All stillbirths in Stockholm 2017

Exclusion Criteria:

• Missed abortion

Related Conditions & MeSH terms

• Fetal Death
• Intra-Uterine Death
• Stillbirth

Intervention

Other:
• 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

Locations

Country	Name	City	State
Sweden	Eva Wiberg-Itzel	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of preventable/non-preventable deaths and the level of delay	to analyze preventable/non-preventable deaths and the level of delay	2017
Secondary	The frequency of different causes of death	To analyze the different causes of death	2017