A Cluster-randomized Controlled Trial on New Community Partnerships Between Community Health Workers (CHWs) and Nurses (CHNs) for Home Visits to Pregnant Women to Increase Skilled Attendant at Birth (SAB) in Rural Ghana
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 952
- Locations
- 1
- Primary Endpoint
- Proportion of women having Skilled Attendant at Birth
Study Overview
Brief Summary
Title: Using Community Health Workers (CHWs) and Nurses (CHNs) to increase Skilled Attendant at Birth (SAB) and improve Maternal and Neonatal Health in Rural Ghana
Background: SAB is a key strategy for improving maternal and new born health since most of the complications occurring at childbirth could be better managed when the delivery is supervised by a doctor, midwife or nurse. The effect of home visits to pregnant women by a CHW/CHN partnership on SAB is yet to be evaluated in a trial in Ghana. This trial will determine the effectiveness of a CHW/CHN home visit intervention to pregnant women on increasing SAB and improving birth outcomes for mothers and their neonates.
Methods: Following ethical approval, we will train CHWs and CHNs to provide a package of health education and support for delivery during three home visits to each pregnant woman. This partnership will be evaluated through a cluster randomized controlled trial in 20 electoral areas in Ellembelle district of Ghana: 10 will be randomized to receive the CHW/CHN partnership intervention and 10 to the control arm (usual care), with a target recruitment of 46-50 women per cluster. The CHWs and CHNs will receive technical and financial support throughout the study.
Data on SAB, maternal utilization of safe practices during pregnancy, breast feeding initiation, exclusive breastfeeding, immunization coverage for mother and new born, maternal deaths and neonatal death rates will be collected. The impact of the CHW/CHN intervention on these indicators will be reported.
Keywords: Community Health Nurse, Community Health Worker, Maternal, New born, Supervised delivery, Post-natal, Effectiveness
Detailed Description
Methods: Assignment of interventions (for controlled trials) Implementation of intervention, Randomization process Randomization of the 20 electoral areas will be done by a statistician. There will be block randomization of clusters depending on the availability of either a Community Health Nurse midwife or a staff midwife within the Electoral area. The block randomization will ensure adequate distribution of intervention and control arms across all the categories of healthcare services available.
Participants will be assigned to intervention or control once informed consent is given, based on their electoral area. All participants in a cluster will be recruited at a health facility located within the electoral area. Participants will not know which group they belong at the time of consent to reduce selection bias. Following random allocation and assignment to either intervention or the control arm, the groups will continue their usual antenatal care of at least four ANC visits as part of the components of Focused Antenatal Care (FANC) services at facility level. Participants will also have access to all on-going health interventions available for all pregnant women. The interventional arm will in addition to their usual care, receive up to three home visits by the CHW/CHN where specific health information will be provided to the woman.
The demographics of women in the two arms will be compared to determine if any differential take-up resulted in unbalanced groups. There may be other consequences of differential take-up that are not evidenced by a comparison of participant demographics; this will be a limitation of the research but cannot be further mitigated.
Sample size In calculating the sample size, the weighted average of the baseline SAB rate of 37% from 2017 actual data for four health sub-districts and the intra-cluster correlation of 0.033, reported from three studies by Pagel et al in 2011 were used.
Hence for each of the two arms, there will be 10 electoral areas (clusters) in which 46-50 women will be recruited for a total sample size of 456 per arm. The total sample size of 912 mothers means the trial would have 80% power to detect a relative increase of 35% in the rate of SAB with an alpha of 0.05.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
The independent assessors will not know which women received the intervention or not. It is impossible to blind participants, persons conducting the visits or the researcher in this home visit intervention.
Eligibility Criteria
- Ages
- 15 Years to 49 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All pregnant women age 15-49 years
- •Presenting from 14 to 24 weeks of gestation
- •The woman has completed 13 weeks of gestation
- •The woman resides in the electoral area
- •Resided continuously for three months prior to the start of the study
Exclusion Criteria
- •Pregnant women who have existing complications
- •Woman requiring the care of a specialist
- •Known previous Medical or Surgical history
Arms & Interventions
Intervention Arm
Study group 1 - Home visits by a team made up of a CHW and CHN in addition to all existing usual care practices (see below).
Standardized educational Messages will be given during these scheduled home visits by the CHW-CHN including:
- One visit during the second trimester of the pregnancy
- Two visits during the third trimester of pregnancy
Intervention: Home visits (Other)
Control Arm
Study group 2 (Control) - Existing usual care practices. Usual Care includes at least four antenatal visits and care package which includes education on pregnancy, labour and delivery given at the health facility or at community settings to individuals and/or groups of pregnant women.
Outcomes
Primary Outcomes
Proportion of women having Skilled Attendant at Birth
Time Frame: 12 months
Numerator: Total number of deliveries with a Skilled Attendant at Birth Denominator: Total number of live births per arm
Secondary Outcomes
- - Proportion of pregnant women making the fourth antenatal visit(12 months)
- The breastfeeding initiation coverage within 1 hour after delivery among intervention and control arms(12 months)
- Proportion of exclusively breastfed neonates at month 1(12 months)
- Proportion of women using Insecticide Treated Net (ITN) during pregnancy(12 months)
- Maternal Mortality Rate(12 months)
- Neonatal Mortality Rate(12 months)
Investigators
Dr Marion Okoh-Owusu
PHD Student
University of Warwick