1. Alternative Clinical Trial Designs for Research on Hypertensive Disorders of Pregnancy in Low Resource Settings
Dr Shivaprasad S Goudar MD, MHPE Professor of Physiology & Research Coordinator,
Women's and Children's Health Research Unit, KLE University's Jawaharlal Nehru Medical College, Belgaum, India

2. 1. Community Level Interventions for Pre-eclampsia - CLIP Trial Cluster Randomized Controlled Trial
2. CRADLE 3 (Community Blood Pressure Measurement in Rural Africa and Asia: the Detection of Underlying Pre-eclampsia and Shock)
Stepped-Wedge Randomised Control Trial

3. Community Level Intervention for Pre-eclampsia
CLIP INDIA TRIAL

4. Community Level Interventions for Pre-eclampsia-Cluster Randomized Controlled Trial (CLIP Trial)
Objectives
To reduce pre-eclampsia related maternal and perinatal mortality and major morbidity by 20%
To reduce pre-eclampsia related adverse maternal and perinatal events using cost-effective interventions appropriate for low resource settings.

5. CLIP Trial- Study Design

6. Field implementation of Android app
for guiding management of Pre-Eclampsia/Eclampsia

7. Community Level Intervention for Pre-Eclampsia ≈60,000 pregnant women
Maputo & Gaza Provinces
Mozambique
Ogun State
Nigeria
(implementation study only)
Karnataka State
India
Sindh Province
Pakistan

8. Community Blood Pressure Measurement in Rural Africa and Asia: the Detection of Underlying Pre-eclampsia and Shock - CRADLE 3 Stepped-Wedge Randomised Control Trial
Objective
To determine whether the CRADLE package reduces a composite of (all-cause) maternal mortality or major morbidity by ≥25%, in nine LIC areas and one Indian area.

9. CRADLE 3- Study Design
Two-phased multicentre stepped wedge cluster randomised controlled trial of the introduction of the CRADLE package (Vital Signs device and training package) to maternity care settings in LICs.

10. Microlife CRADLE Vital Signs Alert Collaboration with Kings College, London
A semi-automated device for detection of Hypertension and Shock from obstetric hemorrhage and sepsis
One of 30 (among 500) high impact innovations to save lives Reimagining Global Health, Innovation Countdown initiative
In collaboration with Microlife, our team has designed and developed….
It is a semi-automated device, which can be used both as an oscillometric and auscultatory device
It is a hand-help, upper arm device
Unlike many commercially available devices, the Microlife 3AS1-2 has been successfully validated…

11. CRADLE Trial Co-Funded by UK Medical Research Council
Community Blood Pressure Monitoring in Rural Africa and Asia: Detection of UnderLying Pre-Eclampsia and Shock
CRADLE Trial
Co-Funded by UK Medical Research Council
and Department of Biotechnology
Cap Hatien, Haiti
Gokak, India
Free Town, Sierra Leone
Addis, Ethiopia
Mbale, Uganda
Kampala, Uganda
Ndola, Zambia
Zomba, Malawi
Lusaka, Zambia
Harare, Zimbabwe

12. Ethical Issues: Cluster RCTs
Individual autonomy vs community consent
Task shifting of clinical work to Community Health Workers
Contamination in control clusters and common referral facilities
Implementing “standard of care” in control clusters per ministry guidelines, an intervention in itself?

13. Ethical Issues: Stepped-Wedged RCTs
Collection of aggregate outcome data at facility level; waiver of individual consent
Avoids contamination, the pre-randomization period serves as its own control
Because of randomization at intervals, implementation can be achieved with minimal logistic support and by fewer resource personnel
Loss of randomization units during the course of the trial may compromise the integrity of the trial

14. Thank You