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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03640663
Other study ID # Midwif2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date August 30, 2018

Study information

Verified date February 2019
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. This study investigated if the model had impact on important maternal and neonatal health outcomes. A retrospective cohort design was used.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2199
Est. completion date August 30, 2018
Est. primary completion date February 28, 2017
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 44 Years
Eligibility Inclusion Criteria:

- Women with singleton pregnancies residing in rural areas giving birth at Nablus governmental hospital, Palestine

Exclusion Criteria:

- Multiple pregnancies

- Women residing in urban areas

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Midwife led continuity model of care
Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes

Locations

Country Name City State
Palestinian Territory, occupied Palestinian Ministry of Health Nablus West Bank

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital University of Oslo

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type Measure Description Time frame Safety issue
Primary Emergency Caesarean section rate Percentage of women undergoing emergency Caesarean section 17 months
Secondary Premature birth rate Babies born before 37 weeks gestational age 17 months
Secondary Post partum anaemia in the mother Low Hb Level at discharge from hospital 17 months
Secondary Induction of Labour rate The rate of women in each group who received induction of labour 17 months
Secondary Birth weight Weight immediately post partum: Low (<2500g) Very low (<1500) 17 months
Secondary APGAR score 5 minutes post partum APGAR score 17 months
Secondary Referral to neonatal intensive care Rate of babies that were referred to neonatal intensive care during hospital stay 17 months
Secondary Blood transfusion rate post partum Rate of women receiving blood tranfusion during the hospital stay 17 months
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