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Background: The World Health Organisation has designed a pregnancy registry to investigate the effect of maternal drug use on pregnancy outcomes in resource-limited settings. In this sentinel surveillance system, detailed health and drug use data are prospectively collected from the first antenatal clinic visit until delivery. Over and above other clinical records, the registry relies on accurate participant reports about the drugs they use. Qualitative methods were incorporated into a pilot registry study during 2010 and 2011 to examine barriers to women reporting these drugs and other exposures at antenatal clinics, and how they might be overcome. Methods: Twenty-seven focus group discussions were conducted in Ghana, Kenya and Uganda with a total of 208 women either enrolled in the registry or from its source communities. A question guide was designed to uncover the types of exposure data under- or inaccurately reported at antenatal clinics, the underlying reasons, and how women prefer to be asked questions. Transcripts were analysed thematically. Results: Women said it was important for them to report everything they had used during pregnancy. However, they expressed reservations about revealing their consumption of traditional, over-the-counter medicines and alcohol to antenatal staff because of anticipated negative reactions. Some enrolled participants’ improved relationship with registry staff facilitated information sharing and the registry tools helped overcome problems with recall and naming of medicines. Decisions about where women sought care, which influenced medicines used and antenatal clinic attendance, were influenced by pressure within and outside of the formal healthcare system to conform to conflicting behaviours. Conversations also reflected women’s responsibilities for producing a healthy baby. Conclusions: Women in this study commonly take traditional medicines in pregnancy, and to a lesser extent over-the-counter medicines and alcohol. The World Health Organisation pregnancy registry shows potential to enhance their reporting of these substances at the antenatal clinic. However, more work is needed to find optimal techniques for eliciting accurate reports, especially where the detail of constituents may never be known. It will also be important to find ways of sustaining such drug exposure surveillance systems in busy antenatal clinics.
We employed a qualitative study design, using focus group discussions (FGDs) to collect the data. These were nested within a WHO registry pilot study and conducted between July 2010 and August 2011. In each registry site a sample of women attending their first ANC visit were enrolled. ANC nurses in the registry teams were given standardised training in how to elicit information on medical histories and medicine use from enrolled women using a data collection tool which complemented the existing ANC records [8]. A similar tool, with additional fields related to the birth outcome, was used at the time of delivery. Women were also encouraged to maintain a written record of the names of medicines they had used (in notebooks), or collect samples or packets in plastic envelopes supplied. These were then to be brought to the site at routine ANC follow-up visits to help registry staff make an accurate record. The study population for this qualitative component included two main categories of women 1) women of all ages who had been enrolled in the WHO pregnancy registry pilot study being conducted at selected sites in Ghana (Dangme West District Hospital), Kenya (Webuye District Hospital) and Uganda (Iganga District Hospital) and 2) women of child-bearing age, who had experienced at least one pregnancy, living in the communities or catchment areas from which participants for the registry were drawn. The latter category was included to potentially detect influence of the registry methods on reporting. Each site was situated in a rural or semi-rural (small town) location. National figures for women’s use of an ANC for at least 4 visits during pregnancy were 78% in Ghana (2008), 47% in Kenya (2009) and 48% in Uganda (2011); 55% (2008), 44% (2009) and 58% (2011) of women respectively are attended to by a skilled birth attendant during delivery; for 2011 the prevalence of HIV (age 15–49) and annual number of malaria cases are 1.5% and 1,041,260 for Ghana, 6.2 and 1002805 for Kenya and 7.2% and 231,873 for Uganda respectively [15]. There were 12 strata of FGDs, as participants were stratified by country, whether enrolled in the registry or from the registry’s source community, and < or ≥24 years old (the latter because younger women often feel less comfortable in expressing themselves in the presence of older women [16]). Sampling was purposive as regards the strata and where community participants resided in relation to the respective ANCs. Those enrolled in the registry were accessed through liaison with the pilot registry ANC study staff teams, while women in the source community groups were recruited within the catchment areas of each antenatal clinic through households and community groups such as markets. Two to 3 FGDs were to be conducted per strata, with a minimum of 6 participants in each. Senior local social scientists (LY, OE, LMA) supervised the field conduct of FGDs by teams trained according to a manual and standard operating procedures developed by an international coordinator (ENA). The original English version of the FGD question guide was translated and pre-tested in at least one FGD per site to ensure the terminology was locally appropriate. Topics included experiences and perceptions about treatment-seeking in pregnancy, poor birth outcomes, maintaining health and treatment records, the pregnancy registry and reporting information at the ANC. As recall ability is related to the time since exposure to a medicine or other substance it was also important to understand the influences on seeking adequate antenatal care, particularly the first ANC visit, and the types of medicines used. The FGDs were held close to the ANC but in a private space. Audio recordings of each FGD were transcribed directly into English using a meaning-based method, checked for quality and imported into NVivo 9 (QSR International Pty Ltd, 2011). ENA and each country social scientist co-coded at least 2 transcripts (deductively, using the research questions, and inductively) to agree on an initial coding framework before ENA completed coding for all countries. Each transcript was read several times before relevant text was examined for repeating concepts (codes) which were labelled and grouped into categories and themes reflecting the underlying meaning behind statements [17]. Quotes that represented the categories and themes were then selected for inclusion in this manuscript. Code counts were also used to express the size of some categories. Approval from the ethical committees or boards of the following institutions was obtained before the WHO pilot registry study started in each respective country: the WHO, Ghana Health Service, Moi Teaching and Referral Hospital, Makerere University Faculty of Medicine, and the Uganda National Council for Science and Technology. The University of Cape Town Human Research Ethics Committee also approved the analysis plan. Informed consent processes and forms for the FGDs were available in the local languages and, though information could be explained in a group, each woman met with a facilitator to confirm consent. Participants were informed about who would have access to the data collected, that refusal to participate or withdrawal of consent wouldn't affect their medical care, and that they did not need to discuss anything they were not willing to. No participant withdrew consent. Refreshments were provided during FGDs.
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