Maternal BehaviorNCT03863600
Midwife-led Continuity and Satisfaction With Care - an Observational Case-Control Study in Palestine
An observational study of Maternal Behavior, run by Oslo University Hospital at 1 site in Palestinian Territories.
Trial summary
This study investigate if a midwife-led continuity model of care in Palestine, had impact on rural women's satisfaction with care through the continuum of antenatal, intrapartum and postnatal period. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Maternal Behavior
- What is being tested?
- Midwife-led continuity of care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 May 2017to 1 Mar 2019
- Phase
- Observational
- 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 16 to 50 years
- Women only
- Child, Adult
Study population: Rural women in the West Bank, occupied Palestine
Who may be able to join
- Residing in rural village
- Registered for pregnancy care at the villages governmental clinic
- With singleton pregnancy
- Gave birth the last one to six month
Who cannot join
- Residing in urban areas
- With multiple pregnancy
- Not registered for antenatal care at the local governmental clinic
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Palestinian Ministry of Health
Nablus, West Bank
About this study
Official title: Validation of a Midwifery Model in Palestine
This study investigate if a midwife-led continuity model of care in Palestine, had impact on rural women's satisfaction with care through the continuum of antenatal, intrapartum and postnatal period.
Read the detailed description
Between 2013 and 2016 a midwife-led continuity model of care was implemented in parts of the Palestinian governmental health system, to improve maternal services to women in rural areas on the occupied West Bank. This study investigated if and how the model influenced women's satisfaction with care, through the continuum of the antenatal-, intrapartum- and postnatal period.
Using an observational case-control design to compare the midwife-led continuity model of care with regular maternity care. Women with singleton pregnancies, who had registered for antenatal care at a rural governmental clinic, were during the first six months after birth invited to answer a questionnaire containing 60 questions with a 7-points Likert scale, rating different aspects of satisfaction with care.
- Conditions
- Maternal Behavior
- Being tested
- Midwife-led continuity of care
- Keywords
- Satisfaction with care, Low-middle income country, Continuity of care, Maternal care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midwife-led continuity of careBehavioural
Midwives from governmental hospitals provide antenatal and postnatal case-load-care in rural villages governmental clinics
| Study group | Role | What they receive |
|---|---|---|
| Midwife-led continuity of care | Women receiving midwife-led model of care though the continuum of pregnancy, birth and postnatal period, and who registered at the governmental clinic in a rural village. Receives: Behavioral: Midwife-led continuity of care | |
| Regular care | Women receiving regular maternal care through the continuum of pregnancy, birth and postnatal period, and who registered at the governmental clinic in a rural village. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sum-score satisfaction with care during the continuum of pregnancy,intrapartum and postnatal period
Summarising mean score in all questions measuring satisfaction and dividing on number of questions included
Measured: One to six months after birth
Secondary outcomes (4)
Mean sum-score satisfaction with care during pregnancy
Summarising the mean score of the questions measuring satisfaction with care during pregnancy and dividing on number of questions included
Measured: One to six months after birth
Mean sum-score satisfaction with care during Labour and birth
Summarising mean score of questions measuring satisfaction with care during Labour and birth, dividing on number of questions included
Measured: One to six months after birth
Mean sum-score satisfaction with care during postnatal period
Summarising mean scores of questions measuring satisfaction with care during postnatal period, and dividing on number of questions included
Measured: One to six month after birth
Duration of exclusive breastfeeding
The proportion of women who were still exclusive breastfeeding at the timepoint of interview, adjusted with number of weeks since birth
Measured: One to six month after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 May 2017
- Primary completion31 May 2018
- Study completion1 Mar 2019
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 BehaviorStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- 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
- NCT03863600
- Sponsor's protocol ID
- Midwif 3
- Status last verified
- Jun 2019
- First submitted
- 26 Feb 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The anonymous IPD might be provided upon request
Publications
Mortensen B, Diep LM, Lukasse M, Lieng M, Dwekat I, Elias D, Fosse E. Women's satisfaction with midwife-led continuity of care: an observational study in Palestine. BMJ Open. 2019 Nov 3;9(11):e030324. doi: 10.1136/bmjopen-2019-030324.
PubMed 31685501
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Midwifery Model in Palestine
- ClinicalTrials.gov ID
- NCT03863600
- Acronym / sponsor ID
- Midwif 3
- Conditions
- Maternal Behavior
- Keywords
- Satisfaction with care, Low-middle income country, Continuity of care, Maternal care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 5 Mar 2019 (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.
This study investigate if a midwife-led continuity model of care in Palestine, had impact on rural women's satisfaction with care through the continuum of antenatal, intrapartum and postnatal period.
Detailed description
Between 2013 and 2016 a midwife-led continuity model of care was implemented in parts of the Palestinian governmental health system, to improve maternal services to women in rural areas on the occupied West Bank. This study investigated if and how the model influenced women's satisfaction with care, through the continuum of the antenatal-, intrapartum- and postnatal period.
Using an observational case-control design to compare the midwife-led continuity model of care with regular maternity care. Women with singleton pregnancies, who had registered for antenatal care at a rural governmental clinic, were during the first six months after birth invited to answer a questionnaire containing 60 questions with a 7-points Likert scale, rating different aspects of satisfaction with care.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midwife-led continuity of care | – | Behavioral: Midwife-led continuity of careWomen receiving midwife-led model of care though the continuum of pregnancy, birth and postnatal period, and who registered at the governmental clinic in a rural village. |
| Regular care | – | –Women receiving regular maternal care through the continuum of pregnancy, birth and postnatal period, and who registered at the governmental clinic in a rural village. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Rural women in the West Bank, occupied Palestine
Key inclusion criteria (4 listed)
- Residing in rural village
- Registered for pregnancy care at the villages governmental clinic
- With singleton pregnancy
- Gave birth the last one to six month
Key exclusion criteria (3 listed)
- Residing in urban areas
- With multiple pregnancy
- Not registered for antenatal care at the local governmental clinic
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 |
|---|---|---|
| Midwife-led continuity of careMidwives from governmental hospitals provide antenatal and postnatal case-load-care in rural villages governmental clinics | Behavioural | Midwife-led continuity of care |
Primary outcome
Mean sum-score satisfaction with care during the continuum of pregnancy,intrapartum and postnatal period
Time frame: One to six months after birth
Summarising mean score in all questions measuring satisfaction and dividing on number of questions included
4 secondary outcomes
Mean sum-score satisfaction with care during pregnancy
Time frame: One to six months after birth
Mean sum-score satisfaction with care during Labour and birth
Time frame: One to six months after birth
Mean sum-score satisfaction with care during postnatal period
Time frame: One to six month after birth
Duration of exclusive breastfeeding
Time frame: One to six month after birth
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 11 Jun 2019.
- Derived from this study: PubMed 31685501Mortensen B, Diep LM, Lukasse M, Lieng M, Dwekat I, Elias D, Fosse E. Women's satisfaction with midwife-led continuity of care: an observational study in Palestine. BMJ Open. 2019 Nov 3;9(11):e030324. doi: 10.1136/bmjopen-2019-030324.
- Individual participant dataSharing planned: Undecided. The anonymous IPD might be provided upon request
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Behavior, run by Oslo University Hospital at 1 site in Palestinian Territories.
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 4 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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Mean sum-score satisfaction with care during the continuum of pregnancy,intrapartum and postnatal period (time frame: One to six months after birth). 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 NCT03863600, 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 11 Jun 2019.