Study Protocol

Title: Utilization of portable ultrasound as a means to increase uptake of antenatal care services in rural Uganda 

 

  1. Background

 

According to statistics provided by the World Health Organization, Uganda currently has the 20th highest rate of maternal mortality, and the 15th highest rate of infant mortality in the world.1 Amongst nations in Africa, Uganda has one of the highest population growth rates, with an annual increase in 3.2% and a fertility rate of 6.7%.1 With approximately 1.5 million pregnancies/year, it is estimated that nearly 6000 women will die due to pregnancy related complications (16 mothers/day) – numbers which are exacerbated by poverty, malnutrition, illness, and lack of access to antenatal, peri-natal and postnatal health care services.

 

While maternal and child mortality is prevalent nationwide, the situation is particularly problematic in remote rural regions such as Kabale, which is located in southwestern Uganda. In contrast to the urban regions of Uganda where it is reported that close to 95% of women attend at least one antenatal care clinic (ANC)2 prior to delivery , current data points to only 66% presenting for ANC in rural Kabale3. Additionally, compared to nearly 60% of women delivering in health centers in urban areas, only 30% of births in Kabale take place in health centers, with most births occurring at home.3,4

 

Extreme poverty and malnutrition amongst women in the region have led to high rates of anemia – studies indicate that 64% of pregnant or new mothers are suffering from anemia in Kabale – in addition to high rates of HIV and malaria. As a result, 70% of the population who deliver at home in the Kabale region, are attended only by unqualified midwives who lack the necessary training and equipment to respond to high-risk delivery complications, are facing the risk of experiencing severe bleeding (caused by post-partum hemorrhage), infection (mostly after delivery), hypertensive disorders (eclampsia), obstructed labor, and ultimately, death.4

 

There are multiple contributing factors that are preventing pregnant women living in the Kabale region from receiving maternal healthcare services from trained professionals. These include cost, access, infrastructure, and cultural attitudes.

 

One of the greatest barriers to maternal health is geography and distance from regional centers where maternal health services are provided. The population in Kabale is situated in smaller, rural communities scattered across a geographically mountainous region. As the majority of rural communities are lacking healthcare centers and trained professionals, pregnant women can only receive trained maternal healthcare services outside their communities. However, the distance from their local communities to the regional center where the government hospital and Kigezi Healthcare Foundation’s (KIHEFO) medical and maternity center are currently operating is immense. As a result, the majority of subsistence agriculture households cannot afford the cost to travel to regional centers for antenatal, natal and postnatal care.

 

Cultural attitudes surrounding childbirth, mainly the fear and stigma of receiving maternal healthcare outside home communities, is also problematic to providing pregnant women with professional medical healthcare services, and overall, reducing maternal mortality. This cultural fear is generated largely by a lack of education amongst rural populations in understanding the additional risks associated with childbirth due to realities of poverty, malnutrition, disease and illness. As a result, many pregnant women who are living in rural communities maintain the preference to give birth at home, despite lacking access to trained birth attendants who can respond to high-risk complications that arise, and facing high rates of maternal mortality.

 

Consultations with local health care workers and community leaders during a medical mission in March 2013 suggested that a significant additional barrier to care is that local women do not appreciate the benefits of routine antepartum screening and treatment. In fact, when antenatal medical services are offered free of charge in a local context women often fail to turn out for the program. At present, local antenatal care includes a general examination including blood pressure testing, maternal hemoglobin testing, maternal voluntary HIV counseling and testing, serology for syphilis, Hepatitis B surface antigen testing, syndromic management for sexually transmitted infections and provision of free maternal iron and folate as well as presumptive treatment for malaria using fansidar as per WHO guidelines. If HIV is diagnosed, free antiretrovirals are offered as part of the national program. Similarly, benzathine penicillin G therapy is administered to patients with a positive treponemal test for syphilis with the resultant prevention of long-term maternal complications as well as the severe complications to the infant of congenital syphilis. Hepatitis B vaccine is also offered to all infants of mothers who are Hep BsAg positive (as per routine Ugandan national guidelines).

 

Although this comprehensive approach would offer many potential benefits to both mother and infant, local thought leaders believe that women do not see these interventions as significant, and therefore do not present for care even when mobile free clinics are brought into their communities. The impression of the local medical staff is that the importance of these “low tech” interventions are not appreciated in the general community. On the other hand these same thought leaders have suggested that women would present for care to have the concrete outcome of “seeing a picture of the baby”. In addition to being appealing to women who are pregnant for personal reasons, studies have shown that obstetric ultrasound imaging can prevent many serious complications of pregnancy (listed previously) by providing early diagnosis and intervention. For example, by providing useful information such as whether or not the mother is carrying twins, has an ectopic pregnancy or placenta previa, a mother and her partner can make an informed decision about whether or not to deliver at home with untrained professionals, or a health center where they can receive life-saving treatment.1 Furthermore, the World Health Organization (2003) recognizes ultrasound technology as ideally suited to low and middle income countries, as it is relatively low-cost, low input, and easily maintained and transported. Additionally, studies conducted on the use of ultrasound technology in two rural hospitals in Rwanda have indicated that after an initial training period, an ultrasound program led by local health care providers can be sustainable and lead to accurate diagnoses.2 Ultrasound imaging is beneficial to rural populations as it is a simple a non-invasive procedure. This helps to reduce levels of fear from women who have previously maintained their cultural preferences for receiving treatment and giving birth with untrained birth attendants in their local villages.3

 

We carried out a small pilot program in March 2013 that screened 48 antenatal women with free mobile ultrasound. We found the technology to work well within the local context and women routinely expressed their appreciation and impression that they were glad they had come and would recommend it to their peers. All of the above routine antenatal screening and interventions were offered at the same time as per routine local guidelines.

 

  1. Hypothesis / Objectives of the study

 

Hypothesis:

Although antenatal care in rural Uganda is hindered by geographic constraints, lack of personal finances and government health care infrastructure, cultural attitudes towards western medicine are also an important concern. Many women do not present for antenatal care as they feel that “just blood testing and tablets” are not reason enough to present for antenatal care. Offering free obstetric ultrasound will significantly increase the number of women in rural Uganda who present for antenatal care.

 

Objectives:

  1. A) To improve maternal attendance at antenatal clinics and thus achieve the following outcomes by implementing routine National Ugandan screening recommendations:
  2. i) To reduce Mother to Child Transmission of HIV
  3. ii) Reduce Mother to child transmission of syphilis, Hepatitis B and prevent malarial complications during pregnancy

iii) Improve maternal preference for delivery with medical professionals

 

  1. B) Identify antepartum risks for increased perinatal complications by offering free ultrasound. In particular, multiple birth, breech presentation, or low-lying placenta; with arrangements to be made for delivery in specialized facilities for women who are thus found to be in need.

 

  1. Design and Methodology

Communities in the Kabale District will be assessed for population size, demographics and birth rate. Communities that have similar characteristics will be selected and contacted to engage in the study. Communities who agree to participate in this study will be contacted and community leaders will make announcements at local schools, churches, and community events regarding the upcoming free antenatal clinics. During these announcements the community will be told either a) that there will be structured maternal health camps [sMHC] offering free obstetric ultrasound [fOBU] or b) that there will be sMHCs with no mention of the fOBU. In actuality, to assure that all women are given the benefit of optimal care, all SMHCs will provide fOBU, but only the advertising messages will differ between groups. Communities will be stratified by catchment population (small, medium or large) prior to randomization and assignment to the intervention or control group. The sMHCs will be organized in collaboration with TO – the WORLD and KIHEFO. The four-pronged approach of MTCT elimination will be followed in the design of the sMHC. This will include primary prevention of HIV, prevention of unintended pregnancies, prevention of vertical transmission and assuring linkages to care treatment and follow-up. Each sMHC will take place over a 12-hour period. All women who appear for clinic will be registered, with demographics recorded, and go through a triage process. They will then receive pre-test counseling for HIV, followed by blood sample collection for onsite testing for HIV/syphilis/hepatitis B, they will then go through family planning sessions, receive a fOBU, will be seen by a triage nurse and then be seen by an MD or DDS (Dentist) depending on their triage needs. All routine care including iron, folate and intermittent presumptive therapy for malaria will be offered free of charge. Women who are found on ultrasound screening to have potential obstetrical high risk pregnancies (low lying placenta, twins, potential birth defects) will be referred for local obstetrical services in Kabale (the regional referral center). Ultrasound will be performed using two Sonosite 180 portable ultrasonographic units operated by two technicians trained to levels of competency as dictated by national guidelines.

 

  1. Justification for Use of Deception

 

Patients will not initially be informed of the study design, which seeks information on how availability of ultrasound will impact their decision to seek out antenatal care. They will receive a questionnaire that will seek to clarify their rationale for seeking care. As this is a major study outcome which could be impacted by knowing the study design, it will be necessary to withhold this information until after the study questionnaire has been completed, i.e. if patients are told that we are aiming to clarify whether the availability of obstetrical ultrasound leads to greater turnout, they may conclude that this is an outcome that the researchers hope to see, and thus to “help the researchers” they will report that ultrasound availability motivated their decision to present for care. Therefore, only after the patients complete their study questionnaires, will they then be informed of the study goals. We do not believe that the study would be possible without this initial (and temporary) non-disclosure, and further there is no potential negative adverse impact of the non-disclosure on the patients. It is important to note that screening obstetrical ultrasound has not previously been available in these communities. The addition of this service (which is routine in developed countries) is an enhancement in service. Therefore, not advertising the availability of the ultrasound in the half of those communities that are randomized to receiving the service but not the notification of it’s availability does not pose a reduction in care from that offered routinely in rural Uganda

 

  1. Inclusion/Exclusion Criteria

 

Inclusion:

The participants must all be residents of the Kabale Region. All pregnant women aged 18 and above who present to one of the sMHCs will be included.

 

Exclusion:

Pregnant women under the age of consent (under 18 years); and any males or non-pregnant females who attend the health camps will be excluded from the study.*

 

Notes:

*All participants excluded from the study will still be offered free medical and dental care as part of a mobile free medical/dental clinic that will be offered in the same community at the same time but in a neighbouring location. For pregnant women under the age of 18, fOBU will also be offered.

 

  1. Age Range

 

Based on a pilot study conducted in 2013 it has been determined that the average age range of participants will be between 18-40 years of age. Any patient presenting to clinic who is under 18 years of age will be excluded from the research study but still offered all medical and dental services.

 

  1. Statistical Design

 

The study design is a cluster randomized controlled trial, whereby communities will be randomly assigned to two groups: the intervention communities will receive outreach messaging that includes information about the availability of fOBU included in medical/dental clinics and the control communities will receive outreach messaging about the availability of medical/dental clinics without mention of the availability of fOBU (although fOBU will be available in both study arms). Outcomes will be assessed at the patient-level (clustered) and the facility-level (ANC uptake).

 

  1. Recruitment Process

 

As described above, participants will be recruited from communities in the Kabale Region by announcements that will be made by community leaders at local schools, churches, and community events regarding the upcoming free antenatal clinics. During these announcements the community will be told either a) that there will be structured maternal health camps (sMHC) offering free obstetric ultrasound (fOBU) or b) that there will be sMHCs with no mention of the fOBU. The recruitment materials will all be in the local language, and will be translated by the local health care workers who are fluent in English and the local Luchiga dialect.

 

  1. Data Collection

Patient care data will be collected in clinical charts during the sMHC. This data will be stored in the local health care facilities as per usual practice. Specifically, all hard copy data obtained on the ground in Kabale will be stored in a locked cabinet in locked room at the KIHEFO offices, only KIHEFO medical staff have access to patient information.

 

Study data will be anonymized and replaced by a study number then kept on a password protected electronic database and analyzed using SPSS. This database will only be made available to the immediate study staff

 

The data will be kept for 7 years. Following this time period the protected electronic database will be deleted.

 

  1. Consent Process

All patients who are seen will be voluntarily attending the sMHC, they will be consented to undergo a fOBU upon checking in at triage and again by the technician. Consents forms will be written in both English and Luchiga and they will be read to patients by KIHEFO staff for those who are not literate in either language.

 

  1. Risk and Benefits

 

Possible Risks:

(i) Physical risks (e.g., any bodily contact or administration of any substance:   Yes      No x

 

(ii) Psychological/emotional risks (e.g., feeling uncomfortable, embarrassed, or upset): Yes x     No

 

(iii) Social risks (e.g., loss of status, privacy and/or reputation):                       Yes      No x

 

(iv) Legal risks (e.g., apprehension or arrest, subpoena):                                  Yes      No x

Notes:

  1. To eliminate any emotional risks of feeling uncomfortable or embarrassed while receiving an obstetric ultrasound all scans will be conducted in a private room with a trained technician. If the technician is male gender the patient will be offered a female chaperone. No additional personnel will be able to observe the ultrasound scan unless they have received specific verbal consent from the patient.

 

Voluntary counseling and testing for HIV and sexually transmitted diseases will be provided as part of routine medical care. The risks associated with this approach are well documented but not altered by study involvement and is strongly advocated by all consensus national and international guidelines. All care will be provided as per Ugandan national guidelines.

 

  1. In this case the intervention – a free obstetric ultrasound – has low risk for potential adverse outcomes. False positive screening ultrasound identifying non-existent congenital anomalies may lead to maternal concern. Any women who have an examination that demonstrates concerning findings will be transferred free of charge to a tertiary care facility for obstetrical consultation and confirmatory testing. Thus, the benefit of early identification and management of true positive tests with prevention of maternal and fetal adverse outcomes will outweigh the potential risk of rare false positive testing.

 

Possible Benefits:

 

The patients will directly benefit from being involved in this project as they will receive free medical and dental care including an obstetric ultrasound. The community will gain a large benefit by having its members leave with improved health and psychological well being of having received medical and dental care. By engaging in this study participants will be providing data on the benefits of maternal screening utilizing portable ultrasound. It will provide the ability to prove that offering free ultrasound scans can increase turnout to maternal care clinics.

 

 

  1. Feedback to Communities

 

Data regarding the number of women screened and the efficacy of ultrasound in attracting participants will be provided in informational sessions to community leaders and then to church and school groups. If the ultrasound is found to either A) identify important obstetrical complications that require intervention in one or more patients or B) enhance maternal presentation for care then the investigators undertake to carry out a fundraising campaign in Canada to purchase portable ultrasound devices and train local staff in the use of ultrasound at the end of the project. This will enable the community to have ongoing benefit from this intervention.

The study results will also be presented at an international meeting and will be submitted for publication in a peer reviewed journal.

 

  1. References

 

  1. Yaw A.W., Alexander T.O., and Edward T.D. The Role of Obstetric Ultrasound in Reducing Maternal and Perinatal Mortality, Ultrasound Imaging – Medical Applications, InTech, Accessed March, 2013. Available from: http://www.intechopen.com/books/ultrasound-imagingmedical-applications/the-role-of-obstetric-ultrasound-in-reducing-maternal-and-perinatal-mortality.
  2. Shah S.P., Epino H., Bukhman G., Umulisa I., Dushimiyimana J.M., Reichman A., Noble V.E. Impact of the introduction of ultrasound services in a limited resource setting: rural Rwanda. BMC International Health Human Rights. 2009;27:9-4
  3. Maternal Health: Investing in the Lifeline of Healthy Societies and Economies. Africa Progress Panel Position Piece. September 2010.

 

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