Prenatal CareNCT03640663
Validation of a Midwifery Model in Palestine 2
An observational study of Prenatal Care, run by Oslo University Hospital at 1 site in Palestinian Territories.
Trial summary
A midwife-led continuity model of care was implemented in governmental maternal facilities in Palestine. Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes. Read more about this study
- Who is it for?
- Ages 15 to 44 years, women only
- Conditions the study is for
- Prenatal Care
- What is being tested?
- Midwife led continuity model of care
- How many people
- 2,199 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Jan 2016to 30 Aug 2018
- How long will I take part?
- 9 Months
- 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 15 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Palestinian women With singleton pregnancies
Who may be able to join
- Women with singleton pregnancies residing in rural areas giving birth at Nablus governmental hospital, Palestine
Who cannot join
- Multiple pregnancies
- Women residing in urban areas
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Palestinian Ministry of Health
Nablus, West Bank
About this study
Official title: The Palestinian Midwifery-led Continuity Model's Effect on Mothers' and Babies' Health Outcomes
A midwife-led continuity model of care was implemented in governmental maternal facilities in Palestine. Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes. This study investigated if the model had impact on important maternal and neonatal health outcomes. A retrospective cohort design was used.
Read the detailed description
Background: A midwife-led continuity model of care was implemented in governmental maternal facilities in Palestine. Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes. This study investigated if the model had impact on important maternal and neonatal health outcomes.
Method: A retrospective cohort design was used. Nablus governmental hospital, Rafidia's medical records were reviewed and data extracted involving 2199 women with singleton pregnancies, residing in rural villages, and their new-born babies born between January 2016 and February 2017. Outcomes were limited to the available information in the hospital's birth registry. Important maternal outcomes were postpartum anaemia (Hb <11), mode of delivery and induction of labour. Important outcomes for new-borns were premature delivery < 37 weeks, birth weight < 2500g and 1500g and referral to neonatal intensive care unit. Outcomes were compared between women receiving the midwife-led continuity model of antenatal care and women receiving regular care.
- Conditions
- Prenatal Care
- Being tested
- Midwife led continuity model of care
- Keywords
- Midwifery-led continuity of care, Birth complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midwife led continuity model of careOther
Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes
| Study group | Role | What they receive |
|---|---|---|
| Midwife led continuity model of care | Women who received antenatal care from midwives from the hospital reaching out to the rural villages Receives: Other: Midwife led continuity model of care | |
| Regular care group | Women who received care from doctors, nurses or midwives employed at primary Health care centres in rural villages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Caesarean section rate
Percentage of women undergoing emergency Caesarean section
Measured: 17 months
Secondary outcomes (7)
Premature birth rate
Babies born before 37 weeks gestational age
Measured: 17 months
Post partum anaemia in the mother
Low Hb Level at discharge from hospital
Measured: 17 months
Induction of Labour rate
The rate of women in each group who received induction of labour
Measured: 17 months
Birth weight
Weight immediately post partum: Low (<2500g) Very low (<1500)
Measured: 17 months
APGAR score 5 minutes post partum
APGAR score
Measured: 17 months
Referral to neonatal intensive care
Rate of babies that were referred to neonatal intensive care during hospital stay
Measured: 17 months
Blood transfusion rate post partum
Rate of women receiving blood tranfusion during the hospital stay
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Jan 2016
- Primary completion28 Feb 2017
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal CareStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,199 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Erik Fosse, Oslo University Hospital
- Investigators
- Erik Fosse, Phd, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640663
- Sponsor's protocol ID
- Midwif2
- Status last verified
- Feb 2019
- First submitted
- 7 Aug 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD can be obtained upon approval of the Palestinian Ministry of Health
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Palestinian Midwifery-led Continuity Model's Effect on Mothers' and Babies' Health Outcomes
- ClinicalTrials.gov ID
- NCT03640663
- Acronym / sponsor ID
- Midwif2
- Conditions
- Prenatal Care
- Keywords
- Midwifery-led continuity of care, Birth complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,199 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 21 Aug 2018 (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.
A midwife-led continuity model of care was implemented in governmental maternal facilities in Palestine. Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes. This study investigated if the model had impact on important maternal and neonatal health outcomes. A retrospective cohort design was used.
Detailed description
Background: A midwife-led continuity model of care was implemented in governmental maternal facilities in Palestine. Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes. This study investigated if the model had impact on important maternal and neonatal health outcomes.
Method: A retrospective cohort design was used. Nablus governmental hospital, Rafidia's medical records were reviewed and data extracted involving 2199 women with singleton pregnancies, residing in rural villages, and their new-born babies born between January 2016 and February 2017. Outcomes were limited to the available information in the hospital's birth registry. Important maternal outcomes were postpartum anaemia (Hb <11), mode of delivery and induction of labour. Important outcomes for new-borns were premature delivery < 37 weeks, birth weight < 2500g and 1500g and referral to neonatal intensive care unit. Outcomes were compared between women receiving the midwife-led continuity model of antenatal care and women receiving regular care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midwife led continuity model of care | – | Other: Midwife led continuity model of careWomen who received antenatal care from midwives from the hospital reaching out to the rural villages |
| Regular care group | – | –Women who received care from doctors, nurses or midwives employed at primary Health care centres in rural villages |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Palestinian women With singleton pregnancies
Key inclusion criteria (1 listed)
- Women with singleton pregnancies residing in rural areas giving birth at Nablus governmental hospital, Palestine
Key exclusion criteria (2 listed)
- Multiple pregnancies
- Women residing in urban areas
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 model of careMidwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes | Other | Midwife led continuity model of care |
Primary outcome
Emergency Caesarean section rate
Time frame: 17 months
Percentage of women undergoing emergency Caesarean section
7 secondary outcomes
Premature birth rate
Time frame: 17 months
Post partum anaemia in the mother
Time frame: 17 months
Induction of Labour rate
Time frame: 17 months
Birth weight
Time frame: 17 months
APGAR score 5 minutes post partum
Time frame: 17 months
Referral to neonatal intensive care
Time frame: 17 months
Blood transfusion rate post partum
Time frame: 17 months
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 28 Feb 2019.
- Individual participant dataSharing planned: Undecided. IPD can be obtained upon approval of the Palestinian Ministry of Health
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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, 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 Prenatal Care, 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 1 inclusion and 2 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 28 Feb 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?
Emergency Caesarean section rate (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2019.