Intra-Uterine DeathNCT04281368
Analysis of All Stillbirths in Stockholm County 2017, a Multidisciplinary Audit
An observational study of Intra-Uterine Death, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Intra-Uterine Death
- What is being tested?
- Analysis of IUFD
- How many people
- 79 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2019to 1 Jan 2020
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: All stillbirths in Stockholm 2017
Who may be able to join
- All stillbirths in Stockholm 2017
Who cannot join
- Missed abortion
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Intra-Uterine Death
- Being tested
- Analysis of IUFD
- Keywords
- IUFD
- Medical subject headings
- Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of IUFDOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of preventable/non-preventable deaths and the level of delay
to analyze preventable/non-preventable deaths and the level of delay
Measured: 2017
Secondary outcomes (1)
The frequency of different causes of death
To analyze the different causes of death
Measured: 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Jun 2019
- Primary completion31 Dec 2019
- Study completion1 Jan 2020
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 Intra-Uterine DeathStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Wiberg-Itzel, Karolinska Institutet
- Investigators
- Eva Wiberg-Itzel, PhD, Principal investigator, KI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281368
- Sponsor's protocol ID
- IUFD
- Status last verified
- Apr 2020
- First submitted
- 20 Feb 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33198695
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of All Stillbirths in Stockholm County 2017, a Multidisciplinary Audit
- ClinicalTrials.gov ID
- NCT04281368
- Acronym / sponsor ID
- IUFD
- Conditions
- Intra-Uterine Death
- Keywords
- IUFD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 24 Feb 2020 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All stillbirths in Stockholm 2017
Key inclusion criteria (1 listed)
- All stillbirths in Stockholm 2017
Key exclusion criteria (1 listed)
- Missed abortion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of IUFDEach 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 | Other | – |
Primary outcome
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
1 secondary outcome
The frequency of different causes of death
Time frame: 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Derived from this study: PubMed 33198695Sterpu 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.
- 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.
Eva Wiberg-Itzel, PhD principal investigator
KI
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 Intra-Uterine Death, run by Karolinska Institutet at 1 site in Sweden.
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 1 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: finished, as of the sponsor's last update on 13 Apr 2020. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of preventable/non-preventable deaths and the level of delay (time frame: 2017). 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 NCT04281368, 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 13 Apr 2020.