DOI: 10.5061/dryad.hhmgqnkj8
title: Randomised trials in maternal and perinatal health in low- and middle-income countries from 2010 to 2019: A systematic scoping review

description: Objectives: To identify and map all trials in maternal health conducted in
 low- and middle-income countries (LMIC) over the 10-year period 2010-2019,
 to identify geographical and thematic trends, as well as compare to global
 causes of maternal death and pre-identified priority areas. Design:
 Systematic scoping review. Primary and secondary outcome measures:
 Extracted data included location, study characteristics and whether trials
 corresponded to causes of mortality and identified research priority
 topics. Results: Our search identified 7,269 articles, 874 of which were
 included for analysis. Between 2010 and 2019, maternal health trials
 conducted in LMICs more than doubled (50 to 114). Trials were conducted in
 61 countries – 231 trials (26.4%) were conducted in Iran. Only 225 trials
 (25.7%) were aligned with a cause of maternal mortality. Within these
 trials, pre-existing medical conditions, embolism, obstructed labour, and
 sepsis were all under-represented when compared with number of maternal
 deaths globally. Large numbers of studies were conducted on priority
 topics such as labour and delivery, obstetric haemorrhage, and antenatal
 care. Hypertensive disorders of pregnancy, diabetes, and health systems
 and policy – despite being high-priority topics – had relatively few
 trials. Conclusion: Despite trials conducted in LMICs increasing from 2010
 to 2019, there were significant gaps in geographical distribution,
 alignment with causes of maternal mortality, and known research priority
 topics. The research gaps identified provide guidance and insight for
 future research conducted in low-resource settings.
description: With support from an information specialist, a search strategy
 was devised to capture eligible studies (Supplemental Table 1). Search
 terms for maternal and perinatal health were derived from search
 strategies used by Cochrane Pregnancy and Childbirth to maintain and
 update their specialised register. We consulted the search filters
 developed by Cochrane EPOC to identify search terms relating to LMICs. The
 search strategy was applied to the Cochrane Central Register of Controlled
 Trials (CENTRAL), which retrieves records from PubMed/MEDLINE, Embase,
 CINAHL, ClinicalTrials.gov, WHO’s International Clinical Trials Registry
 Platform (ICTRP), KoreaMed, Cochrane Review Group’s Specialised Registers,
 and hand-searched biomedical sources. Searching CENTRAL directly had the
 benefit of restricting search results to trials only, keeping the volume
 of citations to screen to a manageable level. Trial register records from
 ClinicalTrials.gov and WHO ICTRP were not included in the records
 retrieved from CENTRAL. The search was conducted on 1 May 2020.
 Citation management, identification of duplicates, and screening
 articles for eligibility were conducted using EndNote and Covidence. Two
 reviewers independently screened titles and abstracts of all retrieved
 citations to identify those that were potentially eligible. Full texts for
 these articles were accessed and assessed by two independent reviewers
 according to the eligibility criteria. At both steps, any disagreements
 were resolved through discussion or consulting a third author.
 <strong>Data collection and
 analysis</strong> For each included trial we
 extracted information on title, author, year of publication, location
 where the trial was conducted (country and SDG region), unit of
 randomisation (individual or cluster), category of intervention,
 intervention level (public health, community, primary care, hospital, and
 health system), and category of the primary outcome(s). The intervention
 and outcome categories were adapted from Cochrane’s list of ‘higher-level
 categories for interventions and outcomes’. For trials with more than one
 primary outcome, we identified a single, most appropriate outcome category
 through discussion and consensus amongst review authors. The level of
 intervention was determined based on the level of the healthcare system
 that the trial was primarily targeting – for example, trials recruiting
 women at an antenatal clinic were classified as primary care level. Public
 health and preventative care were defined as interventions for those in
 the community who were well, while home; and community care was defined as
 interventions for those in the community who were unwell. Based on the
 trial’s primary objective, we tagged each trial to one of 35 maternal
 health topics, as well as classified them by relevance to a cause of
 maternal death identified by Say et al in their global systematic analysis
 (Box 1). Included trials were additionally categorised
 into global research priority topics identified by Souza et al and Chapman
 et al. The research priorities identified by Souza et al were ranked based
 on the distribution of maternal health themes across the 190 priority
 research questions – i.e., the theme with the most research questions was
 considered the highest-ranked priority topic. This mirrored the process
 used by Chapman et al, where research topics with the greatest
 representation within the 100 research questions, based on percentage,
 were given the highest rank. For each trial identified in our review, we
 used the variables extracted to classify it according to priority topics
 identified in Souza et al or Chapman et al, where possible (Box 1). All
 data were extracted by two independent reviewers, with results compared to
 ensure consistency and any disputes resolved through discussion or
 consultation with a third author. As this was a scoping review, we did not
 perform quality assessments on individual trials. We
 conducted descriptive analyses using Excel to determine frequencies of
 extracted variables and used line graphs to explore trends. We assessed
 trends over time using proportions of each variable within studies
 available for a given year. While we initially planned to look at trends
 in individual countries and interventions, many had few or no data
 points.
description: This dataset captures all maternal health trials published to the
 Cochrane CENTRAL database from 2010-2019. It was used to determine trends
 in the data regarding location, the field of interest, and relation to
 both causes of maternal death and research priorities.
 Parameters (Row 1) can be divided into three distinct
 fields: - Paper details (columns A-G)
 - Study details (columns H-O) -
 Classifications (Columns P-S) Drop-down options were
 used for parameters where possible. The lists of drop-down options can be
 found in the following: - Geographical parameters:
 Sheet 2 - Paper details parameters: Sheet 3
 - Classification lists: Sheet 4  
 The following parameter lists were based on the references
 mentioned below: <strong>Intervention and Outcome
 categories: </strong> Cochrane Linked Data.
 Metadata and vocabularies London, UK: The Cochrane Collaboration; 2020
 [cited 2020 June 15]. Available from: https://linkeddata.cochrane.org/linked-data-project/metadata-and-vocabularies <strong>Global causes of maternal death: </strong> Say L, Chou D, Gemmill A, et al. Global causes of maternal death: a WHO systematic analysis. <em>The Lancet Global health</em> 2014; 2(6): e323-33. DOI: https://dx.doi.org/10.1016/S2214-109X(14)70227-X <strong>Souza et. al. 2014</strong> Souza JP, Widmer M, Gulmezoglu AM, et al. Maternal and perinatal health research priorities beyond 2015: an international survey and prioritization exercise. <em>Reprod Health</em> 2014; 11:61. DOI: 10.1186/1742-4755-11-61 <strong>Chapman et. al. 2014</strong> Chapman E, Reveiz L, Sangalang S, et al. A survey study identified global research priorities for decreasing maternal mortality. <em>Journal of Clinical Epidemiology</em> 2014; 67(3): 314-24. DOI: https://doi.org/10.1016/j.jclinepi.2013.10.007