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Completed

NCT Number: NCT01911494

Community Level Interventions for Pre-eclampsia

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.

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Key information

Conditions

Pre-eclampsia Cardiovascular Diseases Death Eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy Induced Hypertension, Pregnancy-Induced Maternal Death Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jawaharlal Nehru Medical College, Karnataka Lingayat Education University, Belagavi, Karnataka, India

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all consenting pregnant women

Exclusion criteria

  • non-pregnant

Treatment and study plan

Community Engagement

Behavioral

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 aid

Device

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 names: CLIP mHealth tool

Magnesium sulfate

Drug

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 names: MgSO4

Methyldopa

Drug

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 names: Aldomet

Primary outcomes

  1. Maternal or Perinatal death or morbidity

    Time frame: within 42 days of pregnancy

    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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Aga Khan University
  • Bill and Melinda Gates Foundation
  • Centro de Investigacao em Saude de Manhica
  • Jawaharlal Nehru Medical College
  • Olabisi Onabanjo University

Registry information

Official study title

The CLIP (Community Level Interventions for Pre-eclampsia) Cluster Randomized Controlled Trial

Acronym: CLIP

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2013
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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