Pre-eclampsiaCLIPNCT01911494
Community Level Interventions for Pre-eclampsia
A study testing Community Engagement, PIERS on the Move mHealth decision aid and Magnesium Sulfate in people with Pre-eclampsia and Hypertension, Pregnancy Induced, run by University of British Columbia at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-eclampsia, Hypertension, Pregnancy Induced
- What is being tested?
- Community Engagement, PIERS on the Move mHealth decision aid and Magnesium Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87,500 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2013to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- all consenting pregnant women
Who cannot join
- non-pregnant
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
India1 site
Jawaharlal Nehru Medical College, Karnataka Lingayat Education University
Belagavi, Karnataka
Nigeria1 site
Centre for Research in Reproductive Health, Olabisi Onabanjo University
Sagamu, Ogun State
About this study
Official title: The CLIP (Community Level Interventions for Pre-eclampsia) Cluster Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Pre-eclampsia, Hypertension, Pregnancy Induced
- Being tested
- Community Engagement, PIERS on the Move mHealth decision aid, Magnesium Sulfate, Methyldopa
- Keywords
- cluster randomized controlled trial, pre-eclampsia, eclampsia, maternal mortality
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Eclampsia, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community EngagementBehavioural
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,
PIERS on the Move mHealth decision aidDevice
Also called CLIP mHealth tool
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.
Magnesium SulfateDrug
Also called MgSO4
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.
MethyldopaDrug
Also called Aldomet
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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) Receives: Behavioral: Community Engagement; Device: PIERS on the Move mHealth decision aid; Drug: Magnesium Sulfate; Drug: Methyldopa |
| Control | No intervention | Current standard of antenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: within 42 days of pregnancy
Secondary outcomes (2)
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.
Measured: from 20 weeks gestation to delivery
Facility births
number of women presenting for delivery in a CEmONC facility in control vs intervention clusters
Measured: from 20 weeks gestation to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Olabisi Onabanjo University, Centro de Investigacao em Saude de Manhica, Aga Khan University, Jawaharlal Nehru Medical College
- Responsible party
- Principal investigator, Peter von Dadelszen, University of British Columbia
- Investigators
- Peter von Dadelszen, MBChB, DPhil, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911494
- Sponsor's protocol ID
- H12-03497
- Other IDs
- F12-01593
- Acronym
- CLIP
- Status last verified
- Jun 2019
- First submitted
- 28 Jun 2013
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24465185von 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.
PubMed 23067947Dunsmuir DT, Payne BA, Cloete G, Petersen CL, Gorges 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.
PubMed 25375683von Dadelszen P, Sandhu A, Bone JN, Qureshi RN, Dada OA, Mallapur AA, Temmerman M, Volvert ML, Waiswa J, Mukhanya M, Mistry HD, Goudar SS, Jah H, Koech A, Sacoor C, Vala A, Munguambe K, Roca A, Adetoro OO, Sevene E, Vidler M, Bellad MB, Sotunsa J, Blencowe HJ, Bhutta ZA, d'Alessandro U, Ansermino JM, Dumont GA, Magee LA; CLIP Trials Study Group; PRECISE Network. Terminal Digit Preference and Threshold Avoidance in Digital Blood Pressure Measurements During Pregnancy: Secondary Analysis of Data From the CLIP and PRECISE Cohorts. JMIR Mhealth Uhealth. 2026 Jun 3;14:e73307. doi: 10.2196/73307.
PubMed 42234864Vidler M, Kinshella MW, Sevene E, Lewis G, von Dadelszen P, Bhutta Z; CLIP Working Group. Transitioning from the "Three Delays" to a focus on continuity of care: a qualitative analysis of maternal deaths in rural Pakistan and Mozambique. BMC Pregnancy Childbirth. 2023 Oct 23;23(1):748. doi: 10.1186/s12884-023-06055-w.
PubMed 37872504Kavi A, Kinshella MW, Ramadurg UY, Charantimath U, Katageri GM, Karadiguddi CC, Honnungar NV, Bannale SG, Mungarwadi GI, Bone JN, Vidler M, Magee L, Mallapur A, Goudar SS, Bellad M, Derman R, von Dadelszen P, Working Group TCI. Community engagement for birth preparedness and complication readiness in the Community Level Interventions for Pre-eclampsia (CLIP) Trial in India: a mixed-method evaluation. BMJ Open. 2022 Dec 20;12(12):e060593. doi: 10.1136/bmjopen-2021-060593.
PubMed 36600428Hoodbhoy Z, Sheikh SS, Qureshi R, Memon J, Raza F, Kinshella MW, Bone JN, Vidler M, Sharma S, Payne BA, Magee LA, von Dadelszen P, Bhutta ZA; CLIP Pakistan Working Group*. Role of community engagement in maternal health in rural Pakistan: Findings from the CLIP randomized trial. J Glob Health. 2021 Jul 17;11:04045. doi: 10.7189/jogh.11.04045. eCollection 2021.
PubMed 34326995Bone JN, Magee LA, Singer J, Nathan H, Qureshi RN, Sacoor C, Sevene E, Shennan A, Bellad MB, Goudar SS, Mallapur AA, Munguambe K, Vidler M, Bhutta ZA, von Dadelszen P; CLIP study group. Blood pressure thresholds in pregnancy for identifying maternal and infant risk: a secondary analysis of Community-Level Interventions for Pre-eclampsia (CLIP) trial data. Lancet Glob Health. 2021 Aug;9(8):e1119-e1128. doi: 10.1016/S2214-109X(21)00219-9. Epub 2021 Jul 5.
PubMed 34237265Bone JN, Khowaja AR, Vidler M, Payne BA, Bellad MB, Goudar SS, Mallapur AA, Munguambe K, Qureshi RN, Sacoor C, Sevene E, Frederix GWJ, Bhutta ZA, Mitton C, Magee LA, von Dadelszen P; CLIP Trials Working Group. Economic and cost-effectiveness analysis of the Community-Level Interventions for Pre-eclampsia (CLIP) trials in India, Pakistan and Mozambique. BMJ Glob Health. 2021 May;6(5):e004123. doi: 10.1136/bmjgh-2020-004123.
PubMed 34031134Makacha L, Makanga PT, Dube YP, Bone J, Munguambe K, Katageri G, Sharma S, Vidler M, Sevene E, Ramadurg U, Charantimath U, Revankar A, von Dadelszen P. Is the closest health facility the one used in pregnancy care-seeking? A cross-sectional comparative analysis of self-reported and modelled geographical access to maternal care in Mozambique, India and Pakistan. Int J Health Geogr. 2020 Feb 3;19(1):1. doi: 10.1186/s12942-020-0197-5.
PubMed 32013994Magee LA, Sharma S, Nathan HL, Adetoro OO, Bellad MB, Goudar S, Macuacua SE, Mallapur A, Qureshi R, Sevene E, Sotunsa J, Vala A, Lee T, Payne BA, Vidler M, Shennan AH, Bhutta ZA, von Dadelszen P; CLIP Study Group. The incidence of pregnancy hypertension in India, Pakistan, Mozambique, and Nigeria: A prospective population-level analysis. PLoS Med. 2019 Apr 12;16(4):e1002783. doi: 10.1371/journal.pmed.1002783. eCollection 2019 Apr.
PubMed 30978179Makanga PT, Sacoor C, Schuurman N, Lee T, Vilanculo FC, Munguambe K, Boene H, Ukah UV, Vidler M, Magee LA, Sevene E, von Dadelszen P, Firoz T; CLIP Working Group. Place-specific factors associated with adverse maternal and perinatal outcomes in Southern Mozambique: a retrospective cohort study. BMJ Open. 2019 Feb 19;9(2):e024042. doi: 10.1136/bmjopen-2018-024042.
PubMed 30782892Sharma 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.
PubMed 28351355Bellad MB, Vidler M, Honnungar NV, Mallapur A, Ramadurg U, Charanthimath U, Katageri G, Bannale S, Kavi A, Karadiguddi C, Sharma S, Lee T, Li J, Payne B, Magee L, von Dadelszen P, Derman R, Goudar SS; CLIP Working Group. Maternal and Newborn Health in Karnataka State, India: The Community Level Interventions for Pre-Eclampsia (CLIP) Trial's Baseline Study Results. PLoS One. 2017 Jan 20;12(1):e0166623. doi: 10.1371/journal.pone.0166623. eCollection 2017.
PubMed 28107350Akeju 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. doi: 10.1186/s12978-016-0216-y.
PubMed 27719681
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CLIP (Community Level Interventions for Pre-eclampsia) Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01911494
- Acronym / sponsor ID
- CLIP / H12-03497
- Conditions
- Pre-eclampsia, Hypertension, Pregnancy Induced
- Keywords
- cluster randomized controlled trial, pre-eclampsia, eclampsia, maternal mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87,500 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Olabisi Onabanjo University, Centro de Investigacao em Saude de Manhica, Aga Khan University, Jawaharlal Nehru Medical College
- Study start
- Sep 2013
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Community Engagement, Device: PIERS on the Move mHealth decision aid, Drug: Magnesium Sulfate, Drug: MethyldopaThe 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) |
| Control | No intervention | –Current standard of antenatal care |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all consenting pregnant women
Key exclusion criteria (1 listed)
- non-pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community EngagementThe 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, | Behavioural | Intervention |
| PIERS on the Move mHealth decision aidAlso: CLIP mHealth toolThis 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. | Device | Intervention |
| Magnesium SulfateAlso: MgSO4Women 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. | Drug | Intervention |
| MethyldopaAlso: AldometWomen 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. | Drug | Intervention |
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)
2 secondary outcomes
Birth preparedness and complication readiness
Time frame: from 20 weeks gestation to delivery
Facility births
Time frame: from 20 weeks gestation to delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Background: PubMed 24465185Payne 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.
- Background: PubMed 23067947von 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.
- Background: PubMed 25375683Dunsmuir DT, Payne BA, Cloete G, Petersen CL, Gorges 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.
- Derived from this study: PubMed 42234864von Dadelszen P, Sandhu A, Bone JN, Qureshi RN, Dada OA, Mallapur AA, Temmerman M, Volvert ML, Waiswa J, Mukhanya M, Mistry HD, Goudar SS, Jah H, Koech A, Sacoor C, Vala A, Munguambe K, Roca A, Adetoro OO, Sevene E, Vidler M, Bellad MB, Sotunsa J, Blencowe HJ, Bhutta ZA, d'Alessandro U, Ansermino JM, Dumont GA, Magee LA; CLIP Trials Study Group; PRECISE Network. Terminal Digit Preference and Threshold Avoidance in Digital Blood Pressure Measurements During Pregnancy: Secondary Analysis of Data From the CLIP and PRECISE Cohorts. JMIR Mhealth Uhealth. 2026 Jun 3;14:e73307. doi: 10.2196/73307.
- Derived from this study: PubMed 37872504Vidler M, Kinshella MW, Sevene E, Lewis G, von Dadelszen P, Bhutta Z; CLIP Working Group. Transitioning from the "Three Delays" to a focus on continuity of care: a qualitative analysis of maternal deaths in rural Pakistan and Mozambique. BMC Pregnancy Childbirth. 2023 Oct 23;23(1):748. doi: 10.1186/s12884-023-06055-w.
- Derived from this study: PubMed 36600428Kavi A, Kinshella MW, Ramadurg UY, Charantimath U, Katageri GM, Karadiguddi CC, Honnungar NV, Bannale SG, Mungarwadi GI, Bone JN, Vidler M, Magee L, Mallapur A, Goudar SS, Bellad M, Derman R, von Dadelszen P, Working Group TCI. Community engagement for birth preparedness and complication readiness in the Community Level Interventions for Pre-eclampsia (CLIP) Trial in India: a mixed-method evaluation. BMJ Open. 2022 Dec 20;12(12):e060593. doi: 10.1136/bmjopen-2021-060593.
- Derived from this study: PubMed 34326995Hoodbhoy Z, Sheikh SS, Qureshi R, Memon J, Raza F, Kinshella MW, Bone JN, Vidler M, Sharma S, Payne BA, Magee LA, von Dadelszen P, Bhutta ZA; CLIP Pakistan Working Group*. Role of community engagement in maternal health in rural Pakistan: Findings from the CLIP randomized trial. J Glob Health. 2021 Jul 17;11:04045. doi: 10.7189/jogh.11.04045. eCollection 2021.
- Derived from this study: PubMed 34237265Bone JN, Magee LA, Singer J, Nathan H, Qureshi RN, Sacoor C, Sevene E, Shennan A, Bellad MB, Goudar SS, Mallapur AA, Munguambe K, Vidler M, Bhutta ZA, von Dadelszen P; CLIP study group. Blood pressure thresholds in pregnancy for identifying maternal and infant risk: a secondary analysis of Community-Level Interventions for Pre-eclampsia (CLIP) trial data. Lancet Glob Health. 2021 Aug;9(8):e1119-e1128. doi: 10.1016/S2214-109X(21)00219-9. Epub 2021 Jul 5.
- Derived from this study: PubMed 34031134Bone JN, Khowaja AR, Vidler M, Payne BA, Bellad MB, Goudar SS, Mallapur AA, Munguambe K, Qureshi RN, Sacoor C, Sevene E, Frederix GWJ, Bhutta ZA, Mitton C, Magee LA, von Dadelszen P; CLIP Trials Working Group. Economic and cost-effectiveness analysis of the Community-Level Interventions for Pre-eclampsia (CLIP) trials in India, Pakistan and Mozambique. BMJ Glob Health. 2021 May;6(5):e004123. doi: 10.1136/bmjgh-2020-004123.
- Derived from this study: PubMed 32013994Makacha L, Makanga PT, Dube YP, Bone J, Munguambe K, Katageri G, Sharma S, Vidler M, Sevene E, Ramadurg U, Charantimath U, Revankar A, von Dadelszen P. Is the closest health facility the one used in pregnancy care-seeking? A cross-sectional comparative analysis of self-reported and modelled geographical access to maternal care in Mozambique, India and Pakistan. Int J Health Geogr. 2020 Feb 3;19(1):1. doi: 10.1186/s12942-020-0197-5.
- Derived from this study: PubMed 30978179Magee LA, Sharma S, Nathan HL, Adetoro OO, Bellad MB, Goudar S, Macuacua SE, Mallapur A, Qureshi R, Sevene E, Sotunsa J, Vala A, Lee T, Payne BA, Vidler M, Shennan AH, Bhutta ZA, von Dadelszen P; CLIP Study Group. The incidence of pregnancy hypertension in India, Pakistan, Mozambique, and Nigeria: A prospective population-level analysis. PLoS Med. 2019 Apr 12;16(4):e1002783. doi: 10.1371/journal.pmed.1002783. eCollection 2019 Apr.
- Derived from this study: PubMed 30782892Makanga PT, Sacoor C, Schuurman N, Lee T, Vilanculo FC, Munguambe K, Boene H, Ukah UV, Vidler M, Magee LA, Sevene E, von Dadelszen P, Firoz T; CLIP Working Group. Place-specific factors associated with adverse maternal and perinatal outcomes in Southern Mozambique: a retrospective cohort study. BMJ Open. 2019 Feb 19;9(2):e024042. doi: 10.1136/bmjopen-2018-024042.
- CLIP trial websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter von Dadelszen, MBChB, DPhil principal investigator
University of British Columbia
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Engagement, PIERS on the Move mHealth decision aid and Magnesium Sulfate in people with Pre-eclampsia and Hypertension, Pregnancy Induced, run by University of British Columbia at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India, Mozambique, Nigeria, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal or Perinatal death or morbidity (time frame: within 42 days of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01911494, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.