Capabilities of Perinatal Healthcare Institutions in the Federation of Bosnia and Herzegovina

Prenatal Care Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06039618
• Other study ID #: 02-09/2-77/20
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2023
• Source: Evangelisches Krankenhaus Bethesda zu Duisburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22897
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Weeks to 42 Weeks

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Infants younger than 22 weeks or older than 42 weeks.

• Infants whose mothers refused to give consent for participation in the study.

Related Conditions & MeSH terms

• Prenatal Care

Intervention

Other:
• Referral to Centre of Higher Organizational Level
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.

Locations

Country	Name	City	State
Bosnia and Herzegovina	General Hospital Tešanj	Tešanj

Sponsors (1)

Lead Sponsor	Collaborator
Evangelisches Krankenhaus Bethesda zu Duisburg

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Referral to a centre of higher organizational level.	Referring the neonate with low birth weight to a more specialized centre.	Before birth and up to 4 hours or more after delivery.