Validation of a Midwifery Model in Palestine 2

February 26, 2019 updated by: Erik Fosse, Oslo University Hospital

The Palestinian Midwifery-led Continuity Model's Effect on Mothers' and Babies' Health Outcomes

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. A retrospective cohort design was used.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

2199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 44 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Palestinian women With singleton pregnancies

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Erik Fosse, Phd, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

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)?

Undecided

IPD Plan Description

IPD can be obtained upon approval of the Palestinian Ministry of Health

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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