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Trial record 1 of 1 for:    stillbirth | Sweden
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Analysis of All Stillbirths in Stockholm County 2017, a Multidisciplinary Audit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04281368
Recruitment Status : Completed
First Posted : February 24, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Eva Wiberg-Itzel, Karolinska Institutet

Brief 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.

Condition or disease Intervention/treatment
Intra-Uterine Death 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.

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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of All Stillbirths in Stockholm County 2017, a Multidisciplinary Audit
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stillbirth


Intervention Details:
  • 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


Primary Outcome Measures :
  1. The rate of preventable/non-preventable deaths and the level of delay [ Time Frame: 2017 ]
    to analyze preventable/non-preventable deaths and the level of delay


Secondary Outcome Measures :
  1. The frequency of different causes of death [ Time Frame: 2017 ]
    To analyze the different causes of death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All stillbirths in Stockholm 2017
Criteria

Inclusion Criteria:

  • All stillbirths in Stockholm 2017

Exclusion Criteria:

  • Missed abortion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04281368


Locations
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Sweden
Eva Wiberg-Itzel
Stockholm, Sweden, 18239
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Eva Wiberg-Itzel, PhD KI
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eva Wiberg-Itzel, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04281368    
Other Study ID Numbers: IUFD
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eva Wiberg-Itzel, Karolinska Institutet:
IUFD
Additional relevant MeSH terms:
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Stillbirth
Fetal Death
Pregnancy Complications
Death
Pathologic Processes