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

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.

Study Overview

• Status: Completed
• Conditions: Intra-Uterine Death
• Intervention / Treatment: Other: Analysis of IUFD

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 18239
    • Eva Wiberg-Itzel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All stillbirths in Stockholm 2017

Description

Inclusion Criteria:

• All stillbirths in Stockholm 2017

Exclusion Criteria:

• Missed abortion

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of different causes of death	To analyze the different causes of death	2017

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Eva Wiberg-Itzel, PhD, KI

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: IUFD
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Stillbirth
• Other Study ID Numbers: IUFD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No