The CLIP trial is 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 has been designed to explore prevailing enablers and barriers for the upcoming implementation of the CLIP cRCT. This study aims to show the feasibility of conducting the CLIP cRCT in selected sites.
We have 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 will be 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 will be unique in that they will rely 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.
For all other countries, use of the package in the Pilot phase is defined as appropriate referral (urgent or non-urgent) to a facility able to provide comprehensive emergency obstetric care (CEmOC) in appropriate women during the first six months of the Pilot CLIP Trial. This accelerated transition from Pilot CLIP Trials to Definitive CLIP Trials will: (i) save resources in the long term as the research infrastructure will be maintained in all countries and, thereby, start-up costs will be reduced as will core infrastructure costs at UBC, and (ii) deliver more rapidly the primary CLIP research question, does the CLIP community intervention improve outcomes for mothers and babies?
Please click here for the latest enrollment numbers.
The CLIP Trial has recruited a total of 76,945 pregnancies since January 2017, and all of the trials have ended the active phase of the recruitment.