Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02587091 |
| Other study ID # |
1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
October 23, 2015 |
| Last updated |
October 26, 2015 |
| Start date |
February 2014 |
| Est. completion date |
February 2014 |
Study information
| Verified date |
October 2015 |
| Source |
Bridge to Health Medical and Dental |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Ministry of Health & Long Term Care, Ontario |
| Study type |
Interventional
|
Clinical Trial Summary
A cluster randomized trial was conducted across eight rural sub-counties in southwestern
Uganda. This study was conducted to determine the impact of advertising free obstetric
ultrasound on the attendance to antenatal care clinics.
Description:
Study Design We conducted a non-blinded cluster-randomized controlled trial to evaluate the
effectiveness of advertising prenatal portable obstetric ultrasound (pOBU) on uptake of
antenatal care (ANC) services. This study design was selected to mitigate confounding
variables and use the natural landscape of the region (described below), which is
conveniently divided into geographically isolated but otherwise homogenous sub-counties, to
our advantage.
The study was conducted in Kabale District, a rural highland located in southwestern Uganda.
It is roughly 560 km from the capital city of Kampala and has a population of approximately
522,000. It is divided into three regions - north, central and south, and is further
subdivided into 22 sub-counties, with 11 in the North, four centrally and seven in the
South.
Ethics approval was obtained from Lakeridge Health Corporation in the city of Oshawa, Canada
as well as Mbarara University of Science and Technology (MUST) in Mbarara, Uganda. The study
protocol can be found at the following link:
http://bridgetohealth.ca/study-protocol/
Study Population All sub-counties of southern and northern regions of Kabale district were
eligible for inclusion as a cluster in this study. This population predominantly engages in
subsistence agriculture. There is very limited data describing the healthcare of this rural
and isolated region, and it is believed that government statistics are often inaccurate. The
Ugandan Ministry of Health, numerous non governmental organizations (NGOs) and other
faith-based organizations provide for the regions' healthcare. Data suggests that uptake of
any ANC services is close to 66%, with only one third of these women returning for a fourth
visit or delivering in a healthcare facility (HCF).
All women who were currently aware of being pregnant and presented to ANC were eligible for
inclusion into the study. No pregnant woman who presented to clinic was excluded from the
study. All patients provided written informed consent on a form developed in collaboration
with the MUST ethics board. Many patients were illiterate or unable to read the consent form
as it was written in English. A bilingual Ugandan midwife, translated the consent form and
verbally explained its contents for each patient as they were checked into the clinic. It
was clearly stated that any patient who chose to not engage in the research study would
still receive full ANC care.
Randomisation and Masking Twenty-two sub-counties were assessed for inclusion, of these 18
were randomised to the intervention (n=4) or control group (n=4). The four sub-counties in
the central region were intentionally excluded from the study design because they are
primarily composed of urban and sub-urban communities and effectively divide the northern
and southern regions. Four control sites (sub-counties) were randomly selected from the
southern wing and four intervention sites were randomly selected from the northern wing.
Selection of northern versus southern counties for intervention or control groups, as well
as selection of which subcounties within each region and in which order they would be
visited was all selected at random. Random selection was conducted by the statisticians at
MUST using a simple random number program in MS-Excel.
All eight sub-counties in the control and treatment arm received advertisement by word of
mouth (WOM) regarding ANC. The control arm received no advertisement of pOBU. When consent
was obtained in the control arm there was intentional masking of pOBU. Following completion
of initial consent and an entrance survey all women were provided with a debriefing form
explaining the presence of ultrasound, including communities where it had not been
advertised, and again consent was obtained to participate in the research study. Any women
who chose to not engage in the research study were provided with complete ANC services,
including pOBU.
Communities were randomly selected as stated above to receive messaging of pOBU. However,
the control communities were chosen to be visited en bloc in the first four days, as opposed
to alternating control then intervention on each day. This was done specifically to avoid
contamination with radio messaging of pOBU, which was felt to possibly cross geographic
boundaries. Sunday was intentionally avoided as a study day as most patients in the
population ascribe to the Catholic faith and would not attend any clinics if held on that
particular day.
Intervention The intervention itself was advertising the availability of clinic and pOBU at
the cluster level (sub-county). The initial study design had only two groups as described
above in randomisation. However, the protocol was amended during the study due to interim
analysis results demonstrating WOM advertising of pOBU was not successful in increasing
uptake of ANC. It was hypothesized that the population was unable to spread this message as
many did not know what pOBU was, and therefore could not relay the message. The intervention
arm was subsequently modified to include radio advertising so that the message could be
delivered more clearly and directly. This resulted in the following three distinct
intervention groups: WOM advertisement of both pOBU and ANC (Intervention A), WOM
advertisement of pOBU and WOM + radio advertisement of ANC (Intervention B), and WOM + radio
advertisement of both pOBU and ANC (Intervention C). The radio message in Intervention C
included the words "You will be able to see a picture of your baby".
All women attending clinic were offered pOBU delivered by a certified Ugandan ultrasound
technician using single Nanomaxx unit with a C60n/8-5 MHz (11-mm broadband curved array)
probe. Patients rotated through an ANC clinic that was based on the WHO guidelines for high
quality ANC5 as well as the WHO four-pronged approach of elimination of mother to child
transmission of HIV (EMTCT).
Women received pre- and post-test counseling and rapid testing for HIV. Those who were
positive were enrolled into the National HIV program and started on antiretroviral therapy
as per national guidelines. Women were also offered intermittent presumptive therapy for
malaria, rapid treponemal testing and treatment for syphilis, hepatitis B screening and
syndromic management of sexually transmitted infections. Iron and folate supplementation was
provided to all women. Any woman in active labour or with a critically low hemoglobin was
transported to hospital by ambulance. Any woman with abnormal findings on ultrasound was
referred for obstetric specialty follow up. All women were encouraged to deliver at a local
HCF.
Survey Women were questioned regarding their experiences and attitudes towards ANC and
intentions to utilize a HFC both on entrance (before being debriefed regarding the
availability of ultrasound) and after receiving the pOBU results. This was performed with
the assistance of a bilingual Ugandan midwife. Data was collected using standardized
electronic patient entrance surveys. The forms captured patient demographic and
socioeconomic data. Patients were also asked if they were aware of the availability of
ultrasound prior to arrival.
Outcomes The primary study outcome was the rate ratio (RR) of total ANC clinic attendance
between the intervention groups and control group. Secondary outcomes included A) the RR of
attendance by women who had previously used a TBA, B) the RR of attendance by women who had
not yet attended ANC, and C) the RR of total attendance between the three interventions.
Statistical Analysis Sub-counties were chosen as the unit of allocation and number of women
accessing ANC in each sub-county as the unit of analysis.
The sample size calculation performed a priori was not utilized for this study as the design
changed during implementation for reasons specified previously. We performed a post-hoc
power calculation. We assumed that the distribution of pregnant women attending ANC was
Poisson distributed. We assumed that the number of pregnant women in each community was
equal (i.e. we assumed equal offsets for control and intervention arms). We assumed that
over-dispersion is not present when conducting the power calculation (i.e. we assumed the
Poisson mean is equal to the Poisson variance). Our goal was to test whether the ratio of
the Poisson rates was equal to 1 (i.e. the rate of women attending ANC was equal in the
control and intervention arms). Assuming a rate ratio of 2, we required 25 women attending
ANC in the control arm and 50 women attending ANC in the intervention arm to achieve 80%
power to reject the null hypothesis of equal rates of attendance. Assuming a rate ratio of
3, we required 10 women attending ANC in the control arm and 30 women attending ANC in the
intervention arm to achieve 80% power to reject the null hypothesis of equal rates of
attendance.
Demographic data was summarized using simple descriptive statistics. We computed rates of
ANC uptake, first ANC use and ANC uptake due to pOBU, respectively, and all at the cluster
level. The count of the number of women attending ANC, for each specific outcome, formed the
numerator of the rate. The ideal denominator for the rate calculation would be the number of
women who were aware that they were pregnant during the study period. This denominator was
unavailable so we used the number of women attending first ANC in 2013-2014 through
government run clinics as a proxy. We expressed all rates per 1,000 women. Using Poisson
regression, and Pearson's correction factor for over-dispersion, we tested whether the ratio
of rates in the control and intervention arms were equal.
We compared the estimated rates in each intervention group with the control group and also
in each intervention group with other intervention groups (we computed all possible
pair-wise rate ratios between trial arms). We chose to reject the null hypothesis of equal
rates of ANC uptake at a 5% alpha level. All statistical analyses were conducted using SAS
version 9.4 (Cary, North Carolina). Since the outcomes reported were at the health facility
(cluster) level, no further special analyses to account for clustering were conducted.
Role of the Funding Source The funding source of this study was the Canadian not for profit
corporation Bridge to Health Medical and Dental (BTH). BTH is primarily funded through
unrestricted donations from Canadian corporations (such as Cole Engineering, Lebovic
Enterprises and other smaller donors), Canadian Rotary Clubs, and small private donors. None
of the donors had any conflicts of interest. None of the Canadian investigators received any
personal compensation for their work on this project. The organization has no proprietary
holdings on the technology used in this study nor does it, or its investigators, receive any
financial compensation for sales of portable ultrasound technology. Some compensation for
time spent was provided by BTH to the Ugandan research team.
