The CLIP Trial is a cluster randomised controlled trial that tests the impact of a package of care specifically designed to improve community level care for women with a hypertensive disorder of pregnancy. This package includes:
Community engagement to improve understanding of the hypertensive disorders of pregnancy with the importance of regular antenatal care.
Regular monitoring of pregnancies by community health care providers in the home or at the primary health centre including blood pressure measurement, urine testing and symptom assessment.
Community level treatment with magnesium sulphate and oral methyldopa when indicated via the use of a mobile health platform.
Recommendation for referral to higher level health facilities for all women identified to be at high risk.
The goal of the CLIP Trial is 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 Karnataka State (India).
The primary outcome for the Pilot CLIP Trials will be common for all participating countries, and will be appropriate use of the CLIP package of care (methyldopa and/or MgSO4 and urgent/non-urgent transport to CEmOC facility) in women with the appropriate CLIP trigger. The Pilot CLIP Trials will recruit for 12 months, primarily to field test: application of the CLIP intervention, data collection, and research infrastructure through four quarterly surveillance cycles (in Nigeria and Pakistan).
The secondary outcomes for the Pilot CLIP Trials will be the adverse maternal and perinatal outcomes.
Monitoring in CLIP Pilot Trial
Monitoring during the Pilot phase of the trial to determine rate of use of the CLIP package of care will be performed by the cHCPs in an ongoing manner after the Pilot trial begins. In the Pilot trial, if the percentage use of the CLIP ‘package of care’ is <50% in any given jurisdiction at 6 months after the trial start date, but climbing, we plan to re-assess at 7, 8, and 9 months before making a decision whether or not to continue the trial. Similarly, if there is an identifiable barrier or number of barriers found then we will attempt to overcome the barrier(s) and reassess, deferring the commencement of the Definitive CLIP trial in that jurisdiction, while proceeding in the others. All decisions will be made by consulting with the BMGF (sponsor), after reviewing the advice of the CLIP trial DSMB, and complying with relevant REB guidance.
The rationale for continuing the Pilot CLIP trial beyond the initial nine months is to beta-test the whole trial process through at least two household surveillance cycles, as well as to test and validate any tools designed specifically for use in the Definitive CLIP trial, but not related to the primary outcome.
The Pilot CLIP trial has generated many lessons for the Definitive Trial. The volume of data generated in the Pilot Trial includes following 15,381 pregnancies, which is a significant number and is only increasing manifold in the Definitive Trial. The Pilot Trial has highlighted the importance of careful monitoring of data quality including timely response to queries, and continuous feedback to trial staff for meeting the trial objectives.