Validation of a Midwifery Model in Palestine 1

Validation of a Midwifery Model in Palestine - Usage and Quality

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.

Study Overview

• Status: Completed
• Conditions: Maternal Health
• Intervention / Treatment: Procedure: Continuity of midwifery care

Detailed Description

In 2013 a program for continuity of midwifery care (midwives at the local hospital provided ante- and post natal care i clinics located in rural villages) in the region Nablus and Jericho on the West Bank, Palestine. By the end of 2013, the model was implemented in 16 of a total of 53 clinics in the region. In order to compare the impact of the continuity of midwifery care on changes in usage of pre- and postnatal services and quality of care, registry data will be obtained from all clinics two years before the implementation (2011-2012) and for two years after the implementation (2014-2015). The following indicators will be compared between the 16 clinics where the program was implemented and comparable clinics where the program has not yet been implemented:

1. Mean number of antenatal visits per woman (Usage primary outcome)
2. Proportion of total pregnant women that visited the clinic (Usage secondary outcome))
3. Percentage of pregnant referred to higher level of care (Quality primary outcome)
4. Percentage of women referred for high blood sugar levels (Quality secondary outcome)
5. Percentage of women receiving postnatal home visits (Quality primary outcome)
6. Proportion of women seen by doctor after birth (Quality secondary outcome)
7. Proportion of newborns seen by doctor after birth (Quality secondary outcome)
8. Total number of consultations for mother and child after birth (Usage secondary outcome)

All data will be obtained from the monthly statistical reports sent from the clinics to the Palestinian Ministry of health.

Data sources, statistical procedures, power and sample size:

The governmental registry includes data from two years before and two years after the implementation. The registry consists of unidentifiable recordings reported monthly from all clinics to the central statistical database in the Ministry of Health. A copy of the heath authority registry was obtained for statistical analysis.

Descriptive and inferential statistics will be used to analyse collected quantitative data. Data will be registered and analysed using the computer statistical package SPSS version 21 and STATA. Prior to analysis all variables will be checked for data file errors.

• Study Type: Interventional
• Enrollment (Actual): 5760
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continuity of midwifery care; Clinics where the continuity of midwifery care program was implemented during 2013	Procedure: Continuity of midwifery care; Pre-natal care in rural villages performed by the midwives from the local hospital
No Intervention: Control; Clinics where no structured changes had been made to the ante- and post- natal care during the period 2013-2015

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antenatal visits	Mean number of antenatal visits in the clinic per woman	0-9 months before delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral	Percentage of pregnant referred to higher level of care	0-12 months after delivery
Home visits	Percentage of women receiving postnatal home visits	0-12 months after delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of visits	Proportion of total pregnant women that visited the clinic	0-9 months before delivery
Blood sugar referral	Percentage of women referred for high blood sugar levels	0-12 months after delivery and 0-9 months before delivery
Doctor follow-up	Proportion of women seen by doctor after birth	0-12 months after delivery
Newborn follow-up	Proportion of newborns seen by doctor after birth	0-12 months after delivery
Consultations post partum	Total number of consultations for mother and child after birth	0-12 months after delivery

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Erik Fosse, MD, Phd, Oslo University Hospital

Publications and helpful links

General Publications

• 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 record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Midwife Palestine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No