Clinical Trial: Community Level Interventions for Pre-eclampsia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: The CLIP (Community Level Interventions for Pre-eclampsia) Cluster Randomized Controlled Trial

Brief Summary:

This project is being undertaken to test the hypothesis that implementing a community based package of care for women with hypertensive disorders of pregnancy will result in overall improvement in maternal and neonatal outcomes. This is based on the premise that there are three main modifiable reasons why women (and their fetuses/newborns) die due to pregnancy complications: 1) delays by the woman herself in recognizing the seriousness of her condition; 2) delays in her being assessed and then transported to a center capable of providing effective and life-saving interventions; and 3) delays in the health facility in providing those interventions. The treatments for pre-eclampsia that are poorly accessed in LMIC are 1) magnesium sulfate (MgSO4) for prevention and treatment of the grand mal seizures of eclampsia; 2) oral antihypertensive medication to lower maternal BP to reduce the risk of stroke.

The CLIP pilot and definitive cRCT will investigate whether the community level intervention including implementation of the CLIP package (oral antihypertensive therapy when indicated, intramuscular (i.m.) MgSO4 when indicated; and appropriate referral to an CEmOC facility when indicated) of care will reduce the incidence of all-cause maternal morbidity and mortality.


Detailed Summary:

We have designed a two-phased community (including PHC-level) cRCT encompassing both rural and urban settings to be fully powered in each of:

  • Ogun State, Nigeria
  • Maputo and Gaza Province, Mozambique
  • Hyderabad and Matiari districts in Sindh Province, Pakistan.
  • Belgaum and Bagalkot districts in 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 will be 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.

A primary component of the CLIP intervention is antenatal risk assessment guided by the PIERS on teh Move mHealth decision aid. The CLIP version of the PIERS on the Move tool (CLIP POM) integrates the miniPIERS predictive score and a clinical data collection system into a single application. Community health workers in each country will assess women according to the visit protocol, entering clinical data into the CLIP POM mobile application. The application will provide recom
Sponsor: University of British Columbia

Current Primary Outcome: Maternal or Perinatal death or morbidity [ Time Frame: within 42 days of pregnancy ]

Combined outcome including any one of the following:

  1. Maternal death (number of deaths during or within 42d of pregnancy or last contact day if contact not maintained to 42d/1000 identified pregnancies); termed Maternal Death Rate.
  2. Maternal morbidity (number of women with ≥1 life-threatening complication of pregnancy (ie eclampsia, major PPH requiring surgical intervention, obstetric sepsis, stroke, etc) during or within 42d of pregnancy or last contact day if contact not maintained to 42d) / 1000 identified pregnancies
  3. Perinatal death (stillbirth [≥20+0 and/or ≥500g], early neonatal mortality [d0-7 of postnatal life] and late neonatal mortality [d8-28 of postnatal life] /1000 identified pregnancies)
  4. Neonatal morbidity (occurrence of any non-lethal morbidity (ie severe breathing difficulty, severe feeding difficulty, seizure, lethargy, coma, hypothermia, skin or umbilical stump infection, jaundice, etc) during 0-28d of postnatal life /1000 identified pregnancies)


Original Primary Outcome: Maternal or Perinatal death or morbidity [ Time Frame: within 42 days of pregnancy ]

Combined outcome including any one of the following:

  1. Maternal death (defined as the number of deaths during pregnancy or within 42 days of pregnancy (or last contact day if contact not maintained to 42 days) / 1,000 identified pregnancies), termed Maternal Death Rate.
  2. Maternal morbidity (defined as the number of women with one or more life-threatening complications of pregnancy (i.e. eclampsia, major PPH requiring surgical intervention, obstetric sepsis, stroke, etc.) during pregnancy or within 42 days of pregnancy or last contact day if contact not maintained to 42 days) / 1,000 identified pregnancies
  3. Perinatal death (defined as stillbirth [≥20+0 and/or ≥500g], early neonatal mortality [d 0-7 of postnatal life] and late neonatal mortality [d 8-28 of postnatal life] / 1,000 identified pregnancies)
  4. Neonatal morbidity (defined as non-lethal events of seizure and coma30 during d 0-28 of postnatal life / 1,000 identified pregnancies)


Current Secondary Outcome:

  • Birth preparedness and complication readiness [ Time Frame: from 20 weeks gestation to delivery ]
    as measured by any three of the following: (1) arranged for transport; (2) obtained prior permission for transport should emergency arise; (3) saved money for obstetric care; (4) identified skilled birth attendant; (5) identified facility for delivery. This will evaluate the success of community engagement.
  • Facility births [ Time Frame: from 20 weeks gestation to delivery ]
    number of women presenting for delivery in a CEmONC facility in control vs intervention clusters


Original Secondary Outcome: Same as current

Information By: University of British Columbia

Dates:
Date Received: June 28, 2013
Date Started: September 2013
Date Completion: December 2017
Last Updated: May 2, 2017
Last Verified: May 2017