Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03907332 |
| Other study ID # |
GHS-ERC: 010/08/18 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
March 2022 |
| Source |
Ghana Health Services |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
The study aims to recruit 46-50 women per cluster. Should no women drop-out of the study, the
sample size required to detect the size of effect sought with enough statistical power would
be 912 (46-50 per cluster).
Blinding The data collectors will be blinded; they would not know which women were in the
intervention or control arms. All data on the primary outcome will be verified by the
researcher, who cannot be blinded. Also, it is impossible to blind the pregnant women and the
CHW/CHNs.
Involvement of District staff The CHWs and CHNs will conduct the visits; one visit in the
second trimester and two in the third trimester- a total of three home visits per pregnant
woman. The district officers will assist in supervising the CHW and CHN visits. Other staff
who will be blinded, will be trained to collect outcomes data.
Methods: Data collection, management, and analysis Data collection methods Initial data on
participants' background characteristics will be documented at the health facility where
recruitment occurs. This will be done by the researcher using a pre-tested data collection
questionnaire (see Appendix 2) and assisted by midwives. Outcome data will be collected from
the pregnant women at the end of the trial by blinded district officers for reliability and
validity. This will be done using a questionnaire administered in the woman's home. The
blinded data collection officers will collect outcomes data only. They will not know which
group the women belong to but the researcher (who will only collect data to verify the
primary outcome and visit acceptability) will.
The data collectors will be trained to respond appropriately in circumstances where mother
experienced a distressful event during pregnancy and /or delivery (offering empathy and
adapting the data collection process intended to avoid any further distress) and contact the
researcher immediately. The researcher will then ensure the social welfare officer is linked
with the affected woman and her family and the needed support provided.
Data Quality All deliveries will be verified by the researcher at the facility or place where
the birth occurred. Also, antenatal visits will be verified from the Maternal health record
book.
Data entries, coding, storage Data will be collected on paper by blinded data collection
officers. The hard copies will be submitted to the researcher at the end of each day's field
work and stored in locked file cabinets at the research unit of the district health
directorate. Entries will be made in MS Excel by the researcher. The Excel database (which
will be anonymous) will be updated to the Warwick email regularly and Supervisors copied. The
hard copies or anonymous soft copies will be made available to the DMEC for data
verification. Check codes using Excel formulae will be built into the database to help
prevent data entry errors and data loss. The entered datasets will be validated by an
independent statistician.
Statistical analyses Statistical tables will be generated, and appropriate statistical tests
used to analyze the variables of interest. Data analyses will be done using STATA version
14.0. Dr Nicholas Parsons and Dr Peter Kimani have provided professional statistics support
and, have agreed to provide further support with the Randomization process through the
school's Statistics Clinic.
The main measure of association to be determined is the Odds Ratios of SAB (OR) in
intervention arm compared to control. The estimated effect of the intervention will be
presented as OR together with its 95% confidence interval. Same will be computed for the
controls. The ORs will be adjusted for clustering . The analysis for each outcome will be by
intention-to-treat and will account for clustering by Electoral area.
Description of subject involved The participants involved are pregnant women. Only women who
reside in Ellembelle will be enrolled in the study. As such women should have lived
continuously in the Electoral area for at least 3 months prior to enrolment into this study.
Enrolment will proceed for eligible participants only after informed consent has been given.
Trial monitoring The Trial Steering Committee (TSC) The TSC has seven members comprising, the
investigator, the research supervisors who are experienced researchers at the University of
Warwick, and four independent policy makers and research experts from the Ghana Health
Service and Ghana's Ministry of Health. They will provide technical guidance on the conduct
of the trial and support timely and efficient dissemination of findings.
The members of the TSC are
1. Dr Marion Okoh-Owusu (Researcher) Contact details: +233206301994; Email:
m.okoh-owusu@warwick.ac.uk
2. Dr Celia Brown (Research Supervisor- Warwick) Contact: celiataylor@warwick.ac.uk
3. Prof Paramjit Gill (Research Supervisor- Warwick)
4. Dr Abraham Hogson M.D, PHD (Research Division- Ghana)
5. Dr Alberta Biritwum-Nyarko MD, MPH, MGCP (Ghana Health Service)
6. Dr Emmanuel Odame MD, MPH, MGCP, (Ministry of Health, Ghana)
7. The Senior Biostatistician, Ghana Health Service
Data Monitoring and Ethics Committee (DMEC) The trial data will be monitored by the DMEC,
which comprises three independent members from Ghana and supported by project supervisors.
DMEC members are:
1. Mr Isaac Korankye- Snr. Biostatistician (Ghana Health Service)
2. Mr Francis Nuoh- Snr. Biostatistician, Ghana Health Service
3. Mr Prince Oppong-Darko - (Health Information Officer)
4. Dr Celia Brown (Research Supervisor- Warwick)
5. Prof Paramjit Gill (Research Supervisor- Warwick)
The DMEC will receive confidential data on the trial, monitor progress and give the relevant
advice where needed. The CHW/CHN trial is a health education intervention delivered in the
pregnant woman's home at the community level, and its evaluation depend on skilled births
occurring within a year, hence the DMEC will not conduct any interim analyses.
