The CLIP Trials are a singular step towards addressing the excess maternal and perinatal mortality that derive from the failure to identify and rapidly manage pre-eclampsia and eclampsia at the community level in LMICs.
To reduce pre-eclampsia-related, and all-cause, maternal and perinatal mortality and major morbidity by 20% or more in intervention clusters in Ogun State (Nigeria), Maputo and Gaza Province (Mozambique), Sindh Province (Pakistan) and in Karnataka State (India).
CLIP is divided into CLIP Feasibility Study, CLIP Pilot Trial and CLIP Definitive Trials.
The CLIP Feasibility Study was designed to explore prevailing enablers and barriers for the upcoming implementation of the CLIP cRCT. This study aimed to show the feasibility of conducting the CLIP cRCT in selected sites.
We designed a two-phase community (including PHC-level) cRCT encompassing both rural and urban settings to be fully powered in each of:
• Ogun State, Nigeria
• Maputo and Gaza Provinces, Mozambique
• Hyderabad and Matiari districts, Sindh Province, Pakistan
• Belgaum and Bagalkot districts, Karnataka State, India
The Trial was phased from the Pilot CLIP Trial to Definitive CLIP Trial on the basis of a satisfactory rate of use (≥50%) of the CLIP ‘package of care’ in appropriate women in all countries but Mozambique. Mozambique was unique in that they relied on an extended period of feasibility to pilot test all Trial systems and tools before directly beginning a definitive trial. Foregoing the Pilot in Mozambique was felt to be appropriate based on their experience with community-based surveillance and will ensure timelines of the trial are met within a manageable budget.
Following the Pilot Trial in Nigeria, and unsurmountable logistical challenges to ensuring robust data collection, the CLIP Trial was halted on 31 January 2016. Logistical challenges in data-entry led to considerable consultation with the local research team, the CLIP Steering Committee, the PRE-EMPT Technical Advisory Group, and the Data Safety and Monitoring Board. Recognising these challenges, and by mutual consent, the difficult decision was made to halt the clinical research trial in Nigeria. This was done under the aegis of the local and institutional research and ethics board. The decision was made to assess the efficacy of the intervention by studying the processes of the delivery and implementation of the CLIP intervention in Sagamu. There are valuable and robust data gathered from the study, including the CLIP visits in which the community health workers used the POM mobile health device to guide the triage, treatment, and transport of hypertensive pregnant women. Important data with strong implications for the mechanics of mobile health-supported task-shifting and levels of community support for community-level interventions have been gathered, and these are being analysed.