NCT03640663

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,199

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

August 7, 2018

Last Update Submit

February 26, 2019

Conditions

Prenatal Care

Keywords

Midwifery-led continuity of careBirth complications

Outcome Measures

Primary Outcomes (1)

  • Emergency Caesarean section rate

    Percentage of women undergoing emergency Caesarean section

    17 months

Secondary Outcomes (7)

  • Premature birth rate

    17 months

  • Post partum anaemia in the mother

    17 months

  • Induction of Labour rate

    17 months

  • Birth weight

    17 months

  • APGAR score 5 minutes post partum

    17 months

  • +2 more secondary outcomes

Study Arms (2)

Midwife led continuity model of care

Women who received antenatal care from midwives from the hospital reaching out to the rural villages

Other: Midwife led continuity model of care

Regular care group

Women who received care from doctors, nurses or midwives employed at primary Health care centres in rural villages

Interventions

Midwife led continuity model of careOTHER

Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes

Midwife led continuity model of care

Eligibility Criteria

Age15 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Palestinian women With singleton pregnancies

You may qualify if:

  • Women with singleton pregnancies residing in rural areas giving birth at Nablus governmental hospital, Palestine

You may not qualify if:

  • Multiple pregnancies
  • Women residing in urban areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palestinian Ministry of Health

Nablus, West Bank, Palestinian Territories

Location

Study Officials

  • Erik Fosse, Phd

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Department

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 21, 2018

Study Start

January 1, 2016

Primary Completion

February 28, 2017

Study Completion

August 30, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations

PA(1)