Maternal HealthNCT03145571
Validation of a Midwifery Model in Palestine 1
A study testing Continuity of midwifery care in people with Maternal Health, run by Oslo University Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maternal Health
- What is being tested?
- Continuity of midwifery care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,760 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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:
- Mean number of antenatal visits per woman (Usage primary outcome)
- Proportion of total pregnant women that visited the clinic (Usage secondary outcome))
- Percentage of pregnant referred to higher level of care (Quality primary outcome)
- Percentage of women referred for high blood sugar levels (Quality secondary outcome)
- Percentage of women receiving postnatal home visits (Quality primary outcome)
- Proportion of women seen by doctor after birth (Quality secondary outcome)
- Proportion of newborns seen by doctor after birth (Quality secondary outcome)
- 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.
- Conditions
- Maternal Health
- Being tested
- Continuity of midwifery care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuity of midwifery careProcedure or surgery
Pre-natal care in rural villages performed by the midwives from the local hospital
| Study group | Role | What they receive |
|---|---|---|
| Continuity of midwifery care | Other | Clinics where the continuity of midwifery care program was implemented during 2013 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antenatal visits
Mean number of antenatal visits in the clinic per woman
Measured: 0-9 months before delivery
Secondary outcomes (2)
Referral
Percentage of pregnant referred to higher level of care
Measured: 0-12 months after delivery
Home visits
Percentage of women receiving postnatal home visits
Measured: 0-12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Jan 2011
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Specific output monitored in villages where the program had been implemented, and where it was not implemented
- Masking
- None (open label)
- Enrolment
- 5,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Fosse, Oslo University Hospital
- Investigators
- Erik Fosse, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145571
- Sponsor's protocol ID
- Midwife Palestine
- Status last verified
- May 2017
- First submitted
- 21 Apr 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29567846
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Midwifery Model in Palestine - Usage and Quality
- ClinicalTrials.gov ID
- NCT03145571
- Acronym / sponsor ID
- Midwife Palestine
- Conditions
- Maternal Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,760 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Mean number of antenatal visits per woman (Usage primary outcome)
- Proportion of total pregnant women that visited the clinic (Usage secondary outcome))
- Percentage of pregnant referred to higher level of care (Quality primary outcome)
- Percentage of women referred for high blood sugar levels (Quality secondary outcome)
- Percentage of women receiving postnatal home visits (Quality primary outcome)
- Proportion of women seen by doctor after birth (Quality secondary outcome)
- Proportion of newborns seen by doctor after birth (Quality secondary outcome)
- 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Specific output monitored in villages where the program had been implemented, and where it was not implemented
| Arm | Type | Receives |
|---|---|---|
| Continuity of midwifery care | Other | Procedure: Continuity of midwifery careClinics where the continuity of midwifery care program was implemented during 2013 |
| Control | No intervention | –Clinics where no structured changes had been made to the ante- and post- natal care during the period 2013-2015 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuity of midwifery carePre-natal care in rural villages performed by the midwives from the local hospital | Procedure or surgery | Continuity of midwifery care |
Primary outcome
Antenatal visits
Time frame: 0-9 months before delivery
Mean number of antenatal visits in the clinic per woman
2 secondary outcomes
Referral
Time frame: 0-12 months after delivery
Home visits
Time frame: 0-12 months after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Derived from this study: PubMed 29567846Mortensen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Fosse, MD, PhD principal investigator
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Continuity of midwifery care in people with Maternal Health, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antenatal visits (time frame: 0-9 months before delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03145571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.