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Community Level Interventions for Pre-eclampsia (CLIP)

Primary Purpose

Pre-eclampsia, Hypertension, Pregnancy Induced

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Community Engagement
PIERS on the Move mHealth decision aid
Magnesium Sulfate
Methyldopa
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pre-eclampsia focused on measuring cluster randomized controlled trial, pre-eclampsia, eclampsia, maternal mortality

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • all consenting pregnant women

Exclusion Criteria:

  • non-pregnant

Sites / Locations

  • Jawaharlal Nehru Medical College, Karnataka Lingayat Education University
  • Centro de Investigacaoem Saude de Manhica (CISM)
  • Centre for Research in Reproductive Health, Olabisi Onabanjo University
  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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)

Current standard of antenatal care

Outcomes

Primary Outcome Measures

Maternal or Perinatal death or morbidity
Combined outcome including any one of the following: 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. 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 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) 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

Birth preparedness and complication readiness
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
number of women presenting for delivery in a CEmONC facility in control vs intervention clusters

Full Information

First Posted
June 28, 2013
Last Updated
June 26, 2019
Sponsor
University of British Columbia
Collaborators
Bill and Melinda Gates Foundation, Olabisi Onabanjo University, Centro de Investigacao em Saude de Manhica, Aga Khan University, Jawaharlal Nehru Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT01911494
Brief Title
Community Level Interventions for Pre-eclampsia
Acronym
CLIP
Official Title
The CLIP (Community Level Interventions for Pre-eclampsia) Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Bill and Melinda Gates Foundation, Olabisi Onabanjo University, Centro de Investigacao em Saude de Manhica, Aga Khan University, Jawaharlal Nehru Medical College

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
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 recommendations for care according to meeting one of the trigger events listed below, as per this protocol. Triggers identified that will indicate treatment and/or transport (urgently, defined as within 4hrs) to a CEmOC facility are as follows: Unconsciousness (MgSO4 if sBP ≥160 mmHg [to be reasonably sure that the unconsciousness is associated with severe pre-eclampsia and not due to obstetric sepsis], urgent transport) Signs of recent stroke or seizure (methyldopa if sBP ≥160 mmHg [to ensure BP is not lowered too much], MgSO4, urgent transport) Significant vaginal bleeding (MgSO4 if sBP ≥140 mmHg [presumed abruption associated with severe pre-eclampsia], urgent transport). No fetal movements felt in the previous 12 hrs (urgent transport [a threshold for identifying at risk fetuses that are alive at the time of screening] 39) sBP ≥160 mmHg (or dBP ≥ 110 mmHg in Nigeria only) (methyldopa, MgSO4, urgent transport [consistent with severe pre-eclampsia]) Heavy proteinuria (≥4+ by dipstick - predictive of stillbirth in miniPIERS cohort, urgent transport) miniPIERS predicted probability ≥25% (MgSO4, urgent transport) Shock index >1.7 in Nigeria only (the Shock index is a ratio of pulse/sBP; high shock index is an indication of poor prognosis in women with postpartum haemorrhage) Non-urgent transport (by non-ambulance services), meaning assessment at a CEmOC facility within 24 hours, will be advised for all women with non-severe hypertension (sBP 140-159 mmHg) who do not meet criteria for one of the above 7/8 triggers. In Mozambique and Pakistan additional CLIP triggers based on use of the audio oximeter will also be included in the POM decision aid. As with the original miniPIERS model, the enhanced model including SpO2 uses a risk threshold of ≥25% predicted probability to identify high-risk cases. Recommendations based on the updated miniPIERS model will include treatment with MgSO4 and urgent referral. An additional independent trigger of SpO2<93% will also be used in Mozambique and Pakistan to indicate urgent referral. In Nigeria where the updated Microlife CRADLE VSA blood pressure device is being used additional triggers will be included for severe diastolic blood pressure or severe shock index to coincide with the traffic light warning signs included in this device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-eclampsia, Hypertension, Pregnancy Induced
Keywords
cluster randomized controlled trial, pre-eclampsia, eclampsia, maternal mortality

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Current standard of antenatal care
Intervention Type
Behavioral
Intervention Name(s)
Community Engagement
Intervention Description
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,
Intervention Type
Device
Intervention Name(s)
PIERS on the Move mHealth decision aid
Other Intervention Name(s)
CLIP mHealth tool
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
MgSO4
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methyldopa
Other Intervention Name(s)
Aldomet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal or Perinatal death or morbidity
Description
Combined outcome including any one of the following: 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. 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 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) 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)
Time Frame
within 42 days of pregnancy
Secondary Outcome Measure Information:
Title
Birth preparedness and complication readiness
Description
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.
Time Frame
from 20 weeks gestation to delivery
Title
Facility births
Description
number of women presenting for delivery in a CEmONC facility in control vs intervention clusters
Time Frame
from 20 weeks gestation to delivery
Other Pre-specified Outcome Measures:
Title
Pre-eclampsia knowledge
Time Frame
from 20 weeks gestation to time of delivery
Title
Post-trial seizures
Description
Assessment of post-trial start eclamptic seizures in control vs intervention clusters to assess effectiveness of community dosing of magnesium sulfate
Time Frame
within 42 days of pregnancy
Title
Cost-effectiveness
Description
Of the CLIP package against QALYs
Time Frame
within 42 days of pregnancy
Title
Adverse effects
Description
Adverse effects of magnesium include injection site hematoma or infection, and respiratory depression
Time Frame
within 42 days of pregnancy
Title
Functional disability
Description
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.
Time Frame
within 6 months of delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all consenting pregnant women Exclusion Criteria: non-pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter von Dadelszen, MBChB, DPhil
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jawaharlal Nehru Medical College, Karnataka Lingayat Education University
City
Belgaum
State/Province
Karnataka
Country
India
Facility Name
Centro de Investigacaoem Saude de Manhica (CISM)
City
Maputo
Country
Mozambique
Facility Name
Centre for Research in Reproductive Health, Olabisi Onabanjo University
City
Sagamu
State/Province
Ogun State
Country
Nigeria
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

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Links:
URL
https://pre-empt.bcchr.ca/treatment/clip-community-level-interventions-pre-eclampsia
Description
CLIP trial website

Learn more about this trial

Community Level Interventions for Pre-eclampsia

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