Community Level Interventions for Pre-eclampsia (CLIP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of British Columbia
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Olabisi Onabanjo University
Centro de Investigacao em Saude de Manhica
Aga Khan University
Jawaharlal Nehru Medical College
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01911494
First received: June 28, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Pre-eclampsia
Hypertension, Pregnancy Induced
Behavioral: Community Engagement
Device: PIERS on the Move mHealth decision aid
Drug: Magnesium Sulfate
Drug: Methyldopa

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The CLIP (Community Level Interventions for Pre-eclampsia) Cluster Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Maternal or Perinatal death or morbidity [ Time Frame: within 42 days of pregnancy ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • Birth preparedness and complication readiness [ Time Frame: from 20 weeks gestation to delivery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    number of women presenting for delivery in a CEmONC facility in control vs intervention clusters


Other Outcome Measures:
  • Pre-eclampsia knowledge [ Time Frame: from 20 weeks gestation to time of delivery ] [ Designated as safety issue: No ]
  • Post-trial seizures [ Time Frame: within 42 days of pregnancy ] [ Designated as safety issue: No ]
    Assessment of post-trial start eclamptic seizures in control vs intervention clusters to assess effectiveness of community dosing of magnesium sulfate

  • Cost-effectiveness [ Time Frame: within 42 days of pregnancy ] [ Designated as safety issue: No ]
    Of the CLIP package against QALYs

  • Adverse effects [ Time Frame: within 42 days of pregnancy ] [ Designated as safety issue: Yes ]
    Adverse effects of magnesium include injection site hematoma or infection, and respiratory depression


Estimated Enrollment: 87500
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
The CLIP intervention consists of (i) community engagement including community leaders, the women of the communities themselves, and their mothers, husbands, and mothers-in-law, regarding pre-eclampsia, its origins, symptoms, signs, and potential consequences, pre-permissions for maternal transport, and fundraising activities around transport and treatment costs; (ii) provision of HDP oriented antenatal care through CLIP visits and use of CLIP "PIERS on the Move" mHealth tool (for risk stratification), and (iii) use of the CLIP package for women with a CLIP 'trigger' (i.e., oral antihypertensive therapy (methyldopa) when indicated, intramuscular (i.m.) magnesium sulfate when indicated; and appropriate referral to an CEmOC facility when indicated)
Behavioral: Community Engagement
The primary objective of the community engagement activities in CLIP will be to create awareness and action around the prevention of maternal morbidity and mortality due to pre-eclampsia/eclampsia. Community engagement involves the collective action of individuals, families, religious leaders, policy makers,
Device: PIERS on the Move mHealth decision aid
This mHealth application is to be used by community health workers in intervention clusters to guide collection of relevant clinical data during antenatal visits. This clinical data is used to generate a risk estimate for any women with hypertension based on the miniPIERS (Pre-eclampsia Integrated Estimate of Risk) clinical risk prediction model. This risk estimate in combination with other pre-defined treatment triggers (severe hypertension (>160mmHg systolic) or proteinuria (>3+ dipstick); absence of fetal movements for greater than 12 hours; signs of recent stroke of seizure) are collected in the app and based on this data recommendations for care of the woman are provided.
Other Name: CLIP mHealth tool
Drug: Magnesium Sulfate
Women identified in intervention clusters by the community health worker during a study visit as being at high risk of- or having recently experienced- an eclamptic seizure will be given 10 g intramuscular magnesium sulfate prior to transfer to a nearby facility for further care.
Other Name: MgSO4
Drug: Methyldopa
Women identified in intervention clusters as having severe hypertension (systolic greater than 160 mmHg) by the community health worker during a study visit will be given 750 mg of oral methyldopa prior to transfer to a nearby facility for further care.
Other Name: Aldomet
No Intervention: Control
Current standard of antenatal care

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all consenting pregnant women

Exclusion Criteria:

  • non-pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911494

Contacts
Contact: Beth Payne bpayne@cw.bc.ca
Contact: Sharla Drebit pre-empt-manager@cw.bc.ca

Locations
India
Jawaharlal Nehru Medical College, Karnataka Lingayat Education University Recruiting
Belgaum, Karnataka, India
Contact: Umesh Charantimath         
Principal Investigator: Mrutunjaya Bellad         
Sub-Investigator: Shivaprasad Goudar         
Sub-Investigator: Ashalata Mallapur         
Mozambique
Centro de Investigacaoem Saude de Manhica (CISM) Not yet recruiting
Maputo, Mozambique
Contact: Esperanca Sevene         
Contact: Eusebio Macete         
Principal Investigator: Esperanca Sevene         
Sub-Investigator: Khatia Munguambe         
Sub-Investigator: Eusebio Macete         
Nigeria
Centre for Research in Reproductive Health, Olabisi Onabanjo University Recruiting
Sagamu, Ogun State, Nigeria
Principal Investigator: Femi Oladapo         
Sub-Investigator: Olukayode A Dada         
Sub-Investigator: Olalekan Adetoro         
Pakistan
Aga Khan University Recruiting
Karachi, Sindh, Pakistan
Principal Investigator: Rahat Qureshi         
Sub-Investigator: Zulfiqar Bhutta         
Sponsors and Collaborators
University of British Columbia
Bill and Melinda Gates Foundation
Olabisi Onabanjo University
Centro de Investigacao em Saude de Manhica
Aga Khan University
Jawaharlal Nehru Medical College
Investigators
Principal Investigator: Peter von Dadelszen, MBChB, DPhil University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01911494     History of Changes
Other Study ID Numbers: H12-03497, F12-01593
Study First Received: June 28, 2013
Last Updated: September 25, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
cluster randomized controlled trial
pre-eclampsia
eclampsia
maternal mortality

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Eclampsia
Hypertension
Pre-Eclampsia
Cardiovascular Diseases
Pregnancy Complications
Vascular Diseases
Magnesium Sulfate
Methyldopa
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Antihypertensive Agents
Autonomic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on October 29, 2014