Validation of a Midwifery Model in Palestine 1

Maternal Health Clinical Trial

Official title:

Validation of a Midwifery Model in Palestine - Usage and Quality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145571
• Other study ID #: Midwife Palestine
• Status: Completed
• Phase: N/A
• First received: April 21, 2017
• Last updated: May 5, 2017
• Start date: January 1, 2011
• Est. completion date: December 31, 2015

Study information

• Verified date: May 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5760
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Maternal Health

Intervention

Procedure:
• Continuity of midwifery care
Pre-natal care in rural villages performed by the midwives from the local hospital

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of visits	Proportion of total pregnant women that visited the clinic	0-9 months before delivery
Other	Blood sugar referral	Percentage of women referred for high blood sugar levels	0-12 months after delivery and 0-9 months before delivery
Other	Doctor follow-up	Proportion of women seen by doctor after birth	0-12 months after delivery
Other	Newborn follow-up	Proportion of newborns seen by doctor after birth	0-12 months after delivery
Other	Consultations post partum	Total number of consultations for mother and child after birth	0-12 months after delivery
Primary	Antenatal visits	Mean number of antenatal visits in the clinic per woman	0-9 months before delivery
Secondary	Referral	Percentage of pregnant referred to higher level of care	0-12 months after delivery
Secondary	Home visits	Percentage of women receiving postnatal home visits	0-12 months after delivery