title: Global women's health: current clinical trials in low- and middle-income countries.
abstract: BACKGROUND
  Clinical trials in low- and middle-income countries (LMICs) are necessary to develop evidence-based approaches to improve women's health. Understanding what research is currently being conducted will allow the identification of research gaps, avoidance of duplication, planning of future studies, collaboration amongst research groups, and geographical targeting for research investments.
  
  
  OBJECTIVE
  To provide an overview of active women's health trials in LMICs.
  
  
  METHODS
  The World Health Organization's International Clinical Trials Registry Platform was searched for trials registered between 1 April 2012 and 31 March 2014.
  
  
  METHODS
  Selected trials were randomised, conducted in LMICs, active, and with a women's health intervention or a significant outcome for the woman.
  
  
  METHODS
  Two reviewers extracted data. Analysis included geographical spread, speciality areas, pre-enrolment registration, study size, and funders.
  
  
  RESULTS
  Of the 8966 records, 509 were eligible for inclusion. Gynaecology trials made up 57% of the research, whereas the remaining 43% of trials were in obstetrics. Research activity focused on fertility (17%), the antenatal period (15%), benign gynaecology (14%), intrapartum care (9%), and pre-invasive disease and cancers (8%). The majority of trials (84%) took place in middle-income countries (MICs). In low-income countries (LICs) 83% of research investigated obstetrics, and in MICs 60% of research investigated gynaecology. Most trials (80%) had a sample size of 500 or fewer participants. The median size of trials in LICs was 815 compared with 128 in MICs. Pre-enrolment registration occurred in 54% of trials. The majority (62%) of trials were funded locally.
  
  
  CONCLUSIONS
  Many LMICs are active in women's health research. The majority of registered trials are located in MICs; however, the trials in LICs are often larger. The focus of research in MICs may be driven by local priorities and funding, with fertility being highly researched. In LICs, pregnancy is the focus, perhaps reflecting the international prioritisation of maternal health.
authors.affiliation: School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK.
authors.forename: A
authors.initials: A
authors.lastname: Merriel
authors.forename: H M
authors.initials: HM
authors.lastname: Harb
authors.forename: H
authors.initials: H
authors.lastname: Williams
authors.forename: R
authors.initials: R
authors.lastname: Lilford
authors.forename: A
authors.initials: A
authors.lastname: Coomarasamy
mesh_terms: D003906:Developing Countries; D005260:Female; D005831:Genital Diseases, Female; D014943:Global Health; D006801:Humans; D008427:Maternal Health Services; D011247:Pregnancy; D011248:Pregnancy Complications; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000592:standards / Q000706:statistics & numerical data*; D060728:Reproductive Health; D016387:Women's Health
keywords: Clinical trial; global; low and middle income; research; women