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Community Level Interventions for Pre-eclampsia (CLIP)

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ClinicalTrials.gov Identifier: NCT01911494
Recruitment Status : Active, not recruiting
First Posted : July 30, 2013
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


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

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The CLIP (Community Level Interventions for Pre-eclampsia) Cluster Randomized Controlled Trial
Study Start Date : September 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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


Other Outcome Measures:
  1. Pre-eclampsia knowledge [ Time Frame: from 20 weeks gestation to time of delivery ]
  2. Post-trial seizures [ Time Frame: within 42 days of pregnancy ]
    Assessment of post-trial start eclamptic seizures in control vs intervention clusters to assess effectiveness of community dosing of magnesium sulfate

  3. Cost-effectiveness [ Time Frame: within 42 days of pregnancy ]
    Of the CLIP package against QALYs

  4. Adverse effects [ Time Frame: within 42 days of pregnancy ]
    Adverse effects of magnesium include injection site hematoma or infection, and respiratory depression

  5. Functional disability [ Time Frame: within 6 months of delivery ]
    Index measurement of functional ability, including ability to care for baby, do household chores and return to work within 6 months of delivery measured at two to four week intervals postpartum.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all consenting pregnant women

Exclusion Criteria:

  • non-pregnant
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911494


Locations
India
Jawaharlal Nehru Medical College, Karnataka Lingayat Education University
Belgaum, Karnataka, India
Mozambique
Centro de Investigacaoem Saude de Manhica (CISM)
Maputo, Mozambique
Nigeria
Centre for Research in Reproductive Health, Olabisi Onabanjo University
Sagamu, Ogun State, Nigeria
Pakistan
Aga Khan University
Karachi, Sindh, Pakistan
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Peter von Dadelszen, Study Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01911494     History of Changes
Other Study ID Numbers: H12-03497
F12-01593 ( Other Grant/Funding Number: Bill and Melinda Gates Foundation )
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

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

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