CLIP Definitive cRCT
To justify continuing on with the Definitive CLIP Trial, by 8 months into the 12 month Pilot (with the exception of India were assessment will occur at 6 months), at least 50% of eligible women (i.e., with a trigger) should have received the package of care.
The primary outcome will be a combined maternal and/or perinatal outcome (either maternal, fetal or neonatal death, or severe morbidity for the mother or baby). We have chosen a combined maternal and/or perinatal outcome as powering a trial for maternal death alone would require a prohibitively large sample size.
As the primary outcome will change between the Pilot and Definitive CLIP Trials, women recruited to the Pilot Trial will be included in the total sample analysed for the Definitive Trial.
Other outcomes will be evaluated such as knowledge of pre-eclampsia/eclampsia among women of reproductive age; total number of seizures; number of pre-admission and post-admission seizures; adverse events; functional disability; and cost-effectiveness of the CLIP intervention. In addition, other outcomes for the perinatal morbidities are congenital anomaly and birth injury.
Functional disability for any reason: Inability to perform usual daily duties at specific points in time during the postpartum period that would be acceptable and expected culturally (we are determining these normal limits through local focus group discussions; these will be defined for each country prior to the commencement of each Pilot CLIP Trial)