- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03640663
Validation of a Midwifery Model in Palestine 2
The Palestinian Midwifery-led Continuity Model's Effect on Mothers' and Babies' Health Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: A midwife-led continuity model of care was implemented in governmental maternal facilities in Palestine. Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes. This study investigated if the model had impact on important maternal and neonatal health outcomes.
Method: A retrospective cohort design was used. Nablus governmental hospital, Rafidia's medical records were reviewed and data extracted involving 2199 women with singleton pregnancies, residing in rural villages, and their new-born babies born between January 2016 and February 2017. Outcomes were limited to the available information in the hospital's birth registry. Important maternal outcomes were postpartum anaemia (Hb <11), mode of delivery and induction of labour. Important outcomes for new-borns were premature delivery < 37 weeks, birth weight < 2500g and 1500g and referral to neonatal intensive care unit. Outcomes were compared between women receiving the midwife-led continuity model of antenatal care and women receiving regular care.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
West Bank
-
Nablus, West Bank, Palestinian Territory, occupied
- Palestinian Ministry of Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women with singleton pregnancies residing in rural areas giving birth at Nablus governmental hospital, Palestine
Exclusion Criteria:
- Multiple pregnancies
- Women residing in urban areas
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Midwife led continuity model of care
Women who received antenatal care from midwives from the hospital reaching out to the rural villages
|
Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes
|
Regular care group
Women who received care from doctors, nurses or midwives employed at primary Health care centres in rural villages
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emergency Caesarean section rate
Time Frame: 17 months
|
Percentage of women undergoing emergency Caesarean section
|
17 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Premature birth rate
Time Frame: 17 months
|
Babies born before 37 weeks gestational age
|
17 months
|
Post partum anaemia in the mother
Time Frame: 17 months
|
Low Hb Level at discharge from hospital
|
17 months
|
Induction of Labour rate
Time Frame: 17 months
|
The rate of women in each group who received induction of labour
|
17 months
|
Birth weight
Time Frame: 17 months
|
Weight immediately post partum: Low (<2500g) Very low (<1500)
|
17 months
|
APGAR score 5 minutes post partum
Time Frame: 17 months
|
APGAR score
|
17 months
|
Referral to neonatal intensive care
Time Frame: 17 months
|
Rate of babies that were referred to neonatal intensive care during hospital stay
|
17 months
|
Blood transfusion rate post partum
Time Frame: 17 months
|
Rate of women receiving blood tranfusion during the hospital stay
|
17 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Erik Fosse, Phd, Oslo University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Midwif2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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