Prenatal CareNCT06039618
Capabilities of Perinatal Healthcare Institutions in the Federation of Bosnia and Herzegovina
An observational study of Prenatal Care, run by Evangelisches Krankenhaus Bethesda zu Duisburg at 1 site in Bosnia and Herzegovina.
Trial summary
The aim of this study is to assess the level of the perinatal healthcare institution (PHI) where the newborns were delivered. We included newborns of both genders that were born in the maternity wards in 10 cantons of the Federation of Bosnia and Herzegovina (FBiH). Read more about this study
- Who is it for?
- Ages 22 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Prenatal Care
- What is being tested?
- Referral to Centre of Higher Organizational Level
- How many people
- 22,897 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 1 Jan 2013to 31 Dec 2017
- 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 22 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborns that were born in the maternity wards of the Federation of Bosnia and Herzegovina
Who may be able to join
- Newborns of both genders that were born in the maternity wards in 10 cantons of the FBiH
- A gestational age between 22 and 42 weeks, and a birth weight less than 2500g.
Who cannot join
- Infants younger than 22 weeks or older than 42 weeks.
- Infants whose mothers refused to give consent for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capabilities of Perinatal Healthcare Institutions in Primary and Tertiary Care of Low Birth Weight Infants in the Federation of Bosnia and Herzegovina: A Cross-sectional Multicentric Study.
The aim of this study is to assess the level of the perinatal healthcare institution (PHI) where the newborns were delivered. We included newborns of both genders that were born in the maternity wards in 10 cantons of the Federation of Bosnia and Herzegovina (FBiH). From the PHI of the first and second level, 159 newborns were referred to the third level. Out of a total of 159 LBWI referred from other PHI, only 19.5% LBWI were transported in less than 4 hours. In second level PHI, most LBWI died in the first 12 hours after birth.
- Conditions
- Prenatal Care
- Being tested
- Referral to Centre of Higher Organizational Level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to Centre of Higher Organizational LevelOther
Referral to Centre of Higher Organizational Level. This means referral from a primary neonatal care center to a secondary one, or from the secondary to the tertiary center.
| Study group | Role | What they receive |
|---|---|---|
| Referred to a Centre of Higher Level | Those are the newborns that were referred at the time of delivery or within one week after birth to centers of higher organizational level. Receives: Other: Referral to Centre of Higher Organizational Level | |
| Treated at the Centre of Admission | Those are the newborns that were not referred to other centers and were treated in the health facility were the birth took place, and hospitalized in the same center until discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral to a centre of higher organizational level.
Referring the neonate with low birth weight to a more specialized centre.
Measured: Before birth and up to 4 hours or more after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Jan 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal CareStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 22,897 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelisches Krankenhaus Bethesda zu Duisburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine Naem, Evangelisches Krankenhaus Bethesda zu Duisburg
- Investigators
- Anis Cerovac, M.D., Principal investigator, General Hospital Tešanj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039618
- Sponsor's protocol ID
- 02-09/2-77/20
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capabilities of Perinatal Healthcare Institutions in Primary and Tertiary Care of Low Birth Weight Infants in the Federation of Bosnia and Herzegovina: A Cross-sectional Multicentric Study.
- ClinicalTrials.gov ID
- NCT06039618
- Acronym / sponsor ID
- 02-09/2-77/20
- Conditions
- Prenatal Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,897 participants (actual)
- Lead sponsor
- Evangelisches Krankenhaus Bethesda zu DuisburgUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 15 Sep 2023 (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.
The aim of this study is to assess the level of the perinatal healthcare institution (PHI) where the newborns were delivered. We included newborns of both genders that were born in the maternity wards in 10 cantons of the Federation of Bosnia and Herzegovina (FBiH). From the PHI of the first and second level, 159 newborns were referred to the third level. Out of a total of 159 LBWI referred from other PHI, only 19.5% LBWI were transported in less than 4 hours. In second level PHI, most LBWI died in the first 12 hours after birth.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referred to a Centre of Higher Level | – | Other: Referral to Centre of Higher Organizational LevelThose are the newborns that were referred at the time of delivery or within one week after birth to centers of higher organizational level. |
| Treated at the Centre of Admission | – | –Those are the newborns that were not referred to other centers and were treated in the health facility were the birth took place, and hospitalized in the same center until discharge. |
Who may qualify
- Ages
- 22 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborns that were born in the maternity wards of the Federation of Bosnia and Herzegovina
Key inclusion criteria (2 listed)
- Newborns of both genders that were born in the maternity wards in 10 cantons of the FBiH
- A gestational age between 22 and 42 weeks, and a birth weight less than 2500g.
Key exclusion criteria (2 listed)
- Infants younger than 22 weeks or older than 42 weeks.
- Infants whose mothers refused to give consent for participation in the study.
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 |
|---|---|---|
| Referral to Centre of Higher Organizational LevelReferral to Centre of Higher Organizational Level. This means referral from a primary neonatal care center to a secondary one, or from the secondary to the tertiary center. | Other | Referred to a Centre of Higher Level |
Primary outcome
Referral to a centre of higher organizational level.
Time frame: Before birth and up to 4 hours or more after delivery.
Referring the neonate with low birth weight to a more specialized centre.
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 18 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Anis Cerovac, M.D. principal investigator
General Hospital Tešanj
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 Prenatal Care, run by Evangelisches Krankenhaus Bethesda zu Duisburg at 1 site in Bosnia and Herzegovina.
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 2 inclusion and 2 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 18 Sep 2023. 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 Bosnia and Herzegovina. 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?
Referral to a centre of higher organizational level. (time frame: Before birth and up to 4 hours or more after delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2023.