Pregnancy registries: providing crucial safety information on the use of drugs during pregnancy
1. Why are pregnancy registries so important?
Pregnancy registries are vital in providing safety information on drugs and vaccines used during pregnancy, particularly within the first trimester, a critical period for the growing baby. There is usually limited data on the safety of drugs by the time they come to the market, and little if any data at all about the safety in pregnancy; therefore, pregnancy registries are crucial to monitor safety in the early post-marketing phase. This information also helps to update drug labelling.
2. How is the data from the registries collected?
We collect information on exposure to prescription and over-the-counter drugs used to treat malaria and other illnesses from women of reproductive age, and link this to information we collect about pregnancies and pregnancy outcomes of interest, such as miscarriage and stillbirths, and from newborn babies at the end of pregnancy including any congenital malformations. We use multiple data sources to ascertain drug exposure, such as data from health facility registers, and interview women attending antenatal clinics at each visit, and at delivery, to inquire about recent drug exposure. We screen newborn babies at delivery and at 6 weeks of age for congenital anomalies. In addition, we will follow a sub-cohort of infants who were exposed to antimalarials in utero1 at 6 months and 1 year of age to screen for congenital anomalies not detected at birth, including congenital heart defects, and assess their neurodevelopment.
3. What challenges did COVID-19 pose?
The COVID-19 pandemic posed multiple challenges. First, we noted reduced antenatal clinic attendance among pregnant women, especially during the 3rd and 4th waves of the pandemic in Kenya. During these periods, we had to adapt the implementation of the study to ensure that staff, participants, and community health workers (CHWs) remained safe, breaking up the field teams to work in cohorts, restricting meetings, and providing masks and hand sanitizer to all staff, including all of the 400 CHWs working closely with the study. Second, we had multiple industrial strikes that interrupted the registry’s data collection activities in government hospitals, but we ensured our presence in private health facilities to which patients were diverted, to minimize gaps in the data. Third, some of our staff, research participants, CHWs and community health volunteers also fell ill. Thankfully, we now have free COVID-19 vaccines available to CHWs and the general population including pregnant women, in local health facilities. The cost of personal protective equipment has also substantially fallen and is now more readily available at hospitals and to the public, which has improved working conditions in medical facilities.
4. What are the next steps?
As of February 2022, we are entering the 11th month of data collection, with one big push for recruitment and pregnancy detection for the last few months of another multiple first-line ACT study – conducted in parallel in the same region as the pregnancy registry – and ending in June 2022. We have also started active data cleaning and merging multiple data sources, including exploring integration with newly introduced electronic medical record systems2 in the study area. Some of our research participants have delivered their children, so we have started to document the babies’ health, including screening for congenital anomalies such as heart defects, and will shortly begin assessing neurocognitive development in a sub-cohort. By October 2023, we should have completed data collection and soon after we will analyse the data and share our findings.
5. What has it been like to work with MMV on this project?
I have to say that this has been one of my favourite collaborations of my career so far. MMV has been a true partner, and it has been an equitable and supportive collaboration. MMV has been hands on and supportive with the field teams led by the Kenya Medical Research Institute and LSTM, sharing their ideas, expertise, and checking in on our progress through joint project meetings. Dr Stephan Duparc from MMV recently visited our project sites in rural Homa Bay and on the islands in Lake Victoria involved in the study, meeting our staff, CHWs and field workers, experiencing the fieldwork that goes into the MiMBa Pregnancy Registry. This was special for us as we rarely experience this level of hands-on collaboration from Global North collaborators and funding partners.
1. In a woman’s uterus.
2. Digital versions of the paper charts used in clinician offices, clinics, and hospitals.
Dr Hellen Barsosio, Senior Clinical Research Scientist, KEMRI/CDC/LSTM Collaboration (KCL)