Community Level Interventions for Pre-eclampsia (CLIP)

Study Description

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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	Phase
Pre-eclampsia; Hypertension, Pregnancy Induced	Behavioral: Community Engagement; Device: PIERS on the Move mHealth decision aid; Drug: Magnesium Sulfate; Drug: Methyldopa	Not Applicable

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Study Design

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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 :	May 2018
Estimated Study Completion Date :	September 2018

Arms and Interventions

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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

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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

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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

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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

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Additional Information:

CLIP trial website 

Publications:

Payne BA, Hutcheon JA, Ansermino JM, Hall DR, Bhutta ZA, Bhutta SZ, Biryabarema C, Grobman WA, Groen H, Haniff F, Li J, Magee LA, Merialdi M, Nakimuli A, Qu Z, Sikandar R, Sass N, Sawchuck D, Steyn DW, Widmer M, Zhou J, von Dadelszen P; miniPIERS Study Working Group. A risk prediction model for the assessment and triage of women with hypertensive disorders of pregnancy in low-resourced settings: the miniPIERS (Pre-eclampsia Integrated Estimate of RiSk) multi-country prospective cohort study. PLoS Med. 2014 Jan;11(1):e1001589. doi: 10.1371/journal.pmed.1001589. Epub 2014 Jan 21.

von Dadelszen P, Firoz T, Donnay F, Gordon R, Justus Hofmeyr G, Lalani S, Payne BA, Roberts JM, Teela KC, Vidler M, Sawchuck D, Magee LA. Preeclampsia in low and middle income countries-health services lessons learned from the PRE-EMPT (PRE-Eclampsia-Eclampsia Monitoring, Prevention and Treatment) project. J Obstet Gynaecol Can. 2012 Oct;34(10):917-926. doi: 10.1016/S1701-2163(16)35405-6. Review.

Dunsmuir DT, Payne BA, Cloete G, Petersen CL, Görges M, Lim J, von Dadelszen P, Dumont GA, Ansermino JM. Development of mHealth applications for pre-eclampsia triage. IEEE J Biomed Health Inform. 2014 Nov;18(6):1857-64. doi: 10.1109/JBHI.2014.2301156.

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

Sharma S, Adetoro OO, Vidler M, Drebit S, Payne BA, Akeju DO, Adepoju A, Jaiyesimi E, Sotunsa J, Bhutta ZA, Magee LA, von Dadelszen P, Dada O. A process evaluation plan for assessing a complex community-based maternal health intervention in Ogun State, Nigeria. BMC Health Serv Res. 2017 Mar 28;17(1):238. doi: 10.1186/s12913-017-2124-4.

Akeju DO, Vidler M, Sotunsa JO, Osiberu MO, Orenuga EO, Oladapo OT, Adepoju AA, Qureshi R, Sawchuck D, Adetoro OO, von Dadelszen P, Dada OA; CLIP Nigeria Feasibility Working Group. Human resource constraints and the prospect of task-sharing among community health workers for the detection of early signs of pre-eclampsia in Ogun State, Nigeria. Reprod Health. 2016 Sep 30;13(Suppl 2):111.

Salam RA, Qureshi RN, Sheikh S, Khowaja AR, Sawchuck D, Vidler M, von Dadelszen P, Zaidi S, Bhutta Z; CLIP working group. Potential for task-sharing to Lady Health Workers for identification and emergency management of pre-eclampsia at community level in Pakistan. Reprod Health. 2016 Sep 30;13(Suppl 2):107.

Ramadurg U, Vidler M, Charanthimath U, Katageri G, Bellad M, Mallapur A, Goudar S, Bannale S, Karadiguddi C, Sawchuck D, Qureshi R, von Dadelszen P, Derman R; Community Level Interventions for Pre-eclampsia (CLIP) India Feasibility Working Group. Community health worker knowledge and management of pre-eclampsia in rural Karnataka State, India. Reprod Health. 2016 Sep 30;13(Suppl 2):113.

Sotunsa JO, Vidler M, Akeju DO, Osiberu MO, Orenuga EO, Oladapo OT, Qureshi R, Sawchuck D, Adetoro OO, von Dadelszen P, Dada OA; CLIP Nigeria Feasibility Working Group. Community health workers' knowledge and practice in relation to pre-eclampsia in Ogun State, Nigeria: an essential bridge to maternal survival. Reprod Health. 2016 Sep 30;13(Suppl 2):108.

Sheikh S, Qureshi RN, Khowaja AR, Salam R, Vidler M, Sawchuck D, von Dadelszen P, Zaidi S, Bhutta Z; CLIP Working Group. Health care provider knowledge and routine management of pre-eclampsia in Pakistan. Reprod Health. 2016 Sep 30;13(Suppl 2):104.

Vidler M, Charantimath U, Katageri G, Ramadurg U, Karadiguddi C, Sawchuck D, Qureshi R, Dharamsi S, von Dadelszen P, Derman R, Goudar S, Mallapur A, Bellad M; Community Level Interventions for Pre-eclampsia (CLIP) India Feasibility Working Group. Community perceptions of pre-eclampsia in rural Karnataka State, India: a qualitative study. Reprod Health. 2016 Jun 8;13 Suppl 1:35. doi: 10.1186/s12978-016-0137-9.

Boene H, Vidler M, Sacoor C, Nhama A, Nhacolo A, Bique C, Alonso P, Sawchuck D, Qureshi R, Macete E, Menéndez C, von Dadelszen P, Sevene E, Munguambe K. Community perceptions of pre-eclampsia and eclampsia in southern Mozambique. Reprod Health. 2016 Jun 8;13 Suppl 1:33. doi: 10.1186/s12978-016-0135-y.

Akeju DO, Vidler M, Oladapo OT, Sawchuck D, Qureshi R, von Dadelszen P, Adetoro OO, Dada OA; CLIP Nigeria Feasibility Working Group. Community perceptions of pre-eclampsia and eclampsia in Ogun State, Nigeria: a qualitative study. Reprod Health. 2016 Jun 8;13 Suppl 1:57. doi: 10.1186/s12978-016-0134-z.

Khowaja AR, Qureshi RN, Sawchuck D, Oladapo OT, Adetoro OO, Orenuga EA, Bellad M, Mallapur A, Charantimath U, Sevene E, Munguambe K, Boene HE, Vidler M, Bhutta ZA, von Dadelszen P; CLIP Working Group. The feasibility of community level interventions for pre-eclampsia in South Asia and Sub-Saharan Africa: a mixed-methods design. Reprod Health. 2016 Jun 8;13 Suppl 1:56. doi: 10.1186/s12978-016-0133-0.

Munguambe K, Boene H, Vidler M, Bique C, Sawchuck D, Firoz T, Makanga PT, Qureshi R, Macete E, Menéndez C, von Dadelszen P, Sevene E. Barriers and facilitators to health care seeking behaviours in pregnancy in rural communities of southern Mozambique. Reprod Health. 2016 Jun 8;13 Suppl 1:31. doi: 10.1186/s12978-016-0141-0.

Qureshi RN, Sheikh S, Khowaja AR, Hoodbhoy Z, Zaidi S, Sawchuck D, Vidler M, Bhutta ZA, von Dadeslzen P; CLIP Working Group. Health care seeking behaviours in pregnancy in rural Sindh, Pakistan: a qualitative study. Reprod Health. 2016 Jun 8;13 Suppl 1:34. doi: 10.1186/s12978-016-0140-1.

Akeju DO, Oladapo OT, Vidler M, Akinmade AA, Sawchuck D, Qureshi R, Solarin M, Adetoro OO, von Dadelszen P; CLIP Nigeria Feasibility Working Group. Determinants of health care seeking behaviour during pregnancy in Ogun State, Nigeria. Reprod Health. 2016 Jun 8;13 Suppl 1:32. doi: 10.1186/s12978-016-0139-7.

Vidler M, Ramadurg U, Charantimath U, Katageri G, Karadiguddi C, Sawchuck D, Qureshi R, Dharamsi S, Joshi A, von Dadelszen P, Derman R, Bellad M, Goudar S, Mallapur A; Community Level Interventions for Pre-eclampsia (CLIP) India Feasibility Working Group. Utilization of maternal health care services and their determinants in Karnataka State, India. Reprod Health. 2016 Jun 8;13 Suppl 1:37. doi: 10.1186/s12978-016-0138-8.

Khowaja AR, Mitton C, Bryan S, Magee LA, Bhutta ZA, von Dadelszen P. Economic evaluation of Community Level Interventions for Pre-eclampsia (CLIP) in South Asian and African countries: a study protocol. Implement Sci. 2015 May 26;10:76. doi: 10.1186/s13012-015-0266-5.

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
Last Update Posted:	May 4, 2018
Last Verified:	May 2018

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