- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03863600
Midwife-led Continuity and Satisfaction With Care - an Observational Case-Control Study in Palestine
Validation of a Midwifery Model in Palestine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Between 2013 and 2016 a midwife-led continuity model of care was implemented in parts of the Palestinian governmental health system, to improve maternal services to women in rural areas on the occupied West Bank. This study investigated if and how the model influenced women's satisfaction with care, through the continuum of the antenatal-, intrapartum- and postnatal period.
Using an observational case-control design to compare the midwife-led continuity model of care with regular maternity care. Women with singleton pregnancies, who had registered for antenatal care at a rural governmental clinic, were during the first six months after birth invited to answer a questionnaire containing 60 questions with a 7-points Likert scale, rating different aspects of satisfaction with care.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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West Bank
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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:
- Residing in rural village
- Registered for pregnancy care at the villages governmental clinic
- With singleton pregnancy
- Gave birth the last one to six month
Exclusion Criteria:
- Residing in urban areas
- With multiple pregnancy
- Not registered for antenatal care at the local governmental clinic
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Midwife-led continuity of care
Women receiving midwife-led model of care though the continuum of pregnancy, birth and postnatal period, and who registered at the governmental clinic in a rural village.
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Midwives from governmental hospitals provide antenatal and postnatal case-load-care in rural villages governmental clinics
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Regular care
Women receiving regular maternal care through the continuum of pregnancy, birth and postnatal period, and who registered at the governmental clinic in a rural village.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean sum-score satisfaction with care during the continuum of pregnancy,intrapartum and postnatal period
Time Frame: One to six months after birth
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Summarising mean score in all questions measuring satisfaction and dividing on number of questions included
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One to six months after birth
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean sum-score satisfaction with care during pregnancy
Time Frame: One to six months after birth
|
Summarising the mean score of the questions measuring satisfaction with care during pregnancy and dividing on number of questions included
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One to six months after birth
|
Mean sum-score satisfaction with care during Labour and birth
Time Frame: One to six months after birth
|
Summarising mean score of questions measuring satisfaction with care during Labour and birth, dividing on number of questions included
|
One to six months after birth
|
Mean sum-score satisfaction with care during postnatal period
Time Frame: One to six month after birth
|
Summarising mean scores of questions measuring satisfaction with care during postnatal period, and dividing on number of questions included
|
One to six month after birth
|
Duration of exclusive breastfeeding
Time Frame: One to six month after birth
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The proportion of women who were still exclusive breastfeeding at the timepoint of interview, adjusted with number of weeks since birth
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One to six month after birth
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Erik Fosse, MD, Phd, Oslo University Hospital
Publications and helpful links
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
- Midwif 3
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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