NCT03145571

Brief Summary

To validate a model of Continuity of Midwifery Care implemented in the region of Nabuls and Jericho in Palestine in 2013, register data from the Palestinian Ministry of Health will be analyzed for the following indicators related to usage and quality. Changes in these variables before and after the implementation will be compared between the 16 clinics where the model was implemented and all comparable clinics in the region.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5,760

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

5 years

First QC Date

April 21, 2017

Last Update Submit

May 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Antenatal visits

    Mean number of antenatal visits in the clinic per woman

    0-9 months before delivery

Secondary Outcomes (2)

  • Referral

    0-12 months after delivery

  • Home visits

    0-12 months after delivery

Other Outcomes (5)

  • Proportion of visits

    0-9 months before delivery

  • Blood sugar referral

    0-12 months after delivery and 0-9 months before delivery

  • Doctor follow-up

    0-12 months after delivery

  • +2 more other outcomes

Study Arms (2)

Continuity of midwifery care

OTHER

Clinics where the continuity of midwifery care program was implemented during 2013

Procedure: Continuity of midwifery care

Control

NO INTERVENTION

Clinics where no structured changes had been made to the ante- and post- natal care during the period 2013-2015

Interventions

Pre-natal care in rural villages performed by the midwives from the local hospital

Continuity of midwifery care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All clinics in Nablus and Jericho governorate located in rural areas, that offer pregnancy- and postnatal-care in the whole study period.
  • Only clinics that had the intervention continuously during the whole observations period (1st of January 2014 and continued till 31st of December 2015) will be included in the intervention group
  • Only the clinics were there were no intervention at all during the whole period will be included in the control group.

You may not qualify if:

  • Clinics located in urban areas (less than three km from Nablus or Jericho city centre).
  • New Clinics that has not been open during the whole study period.
  • Clinics were the intervention was only partially implemented

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mortensen B, Lukasse M, Diep LM, Lieng M, Abu-Awad A, Suleiman M, Fosse E. Can a midwife-led continuity model improve maternal services in a low-resource setting? A non-randomised cluster intervention study in Palestine. BMJ Open. 2018 Mar 22;8(3):e019568. doi: 10.1136/bmjopen-2017-019568.

Study Officials

  • Erik Fosse, MD, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Specific output monitored in villages where the program had been implemented, and where it was not implemented
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2017

First Posted

May 9, 2017

Study Start

January 1, 2011

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

May 9, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share