An mHealth Strategy to Reduce Pre-Eclampsia and Infant Death in Tanzania

Not Applicable

Completed

• Conditions: Pre-Eclampsia; Eclampsia; Hypertension, Pregnancy-Induced
• Interventions: Other: Community-based Pre-eclampsia/Eclampsia Detection and Management; Other: Strengthened Referral Network from Community to Referral hospital levels

• Registration Number: NCT03978429
• Lead Sponsor: Dr. Karen Yeates

Brief Summary

The core of this study is a cluster randomized controlled trial (RCT) of antenatal clinics which are located in four districts in Tanzania. We are conducting an effectiveness (pragmatic) rather than an efficacy (explanatory) trial because we are looking to measure the degree of benefit under 'real world' conditions. Although pragmatic and carried out in real world conditions, the proposed size and scope of the trial will allow us to achieve a robust evaluation of outcomes and determine the effectiveness of our intervention. A cluster design is the most appropriate type of methodology (rather than individual randomization by pregnant woman) as the intervention can be delivered to the entire health facility (of those facilities in the intervention group). The intervention is to implement an mHealth strategy to improve detection and management of PE (pre-eclampsia). This study is a multi-level, mixed-methods design that includes a cluster-randomized controlled trial (RCT) of antenatal clinics in rural Tanzania. Thirty health facilities have been randomized to control facilities and thirty facilities have been randomized to intervention clinics. All randomized clinics have upgraded antenatal care (ANC) and skilled birth attendants present. Nurses in the intervention clinics in this cluster arm will receive mHealth-based education in detection and management of PE and will be instructed and encouraged to follow a guideline-driven approach supported by mHealth (educational modules that provide decision support and reminders through the facility smartphone/tablet). At all antenatal visits, pregnant women will have their blood pressures measured and urine assessed for proteinuria, and, the result will be automatically sent by SMS (short message service) with a unique patient identifier to a central site for monitoring and tracking. Community Health Workers (CHWs) linked to the facility site and local communities will be instructed on which women to have follow-up visits within their communities. For all those women found to be at risk for PE (as well as other high risk maternal conditions), an SMS will be sent to the CHW, and, the nurses at the ANC recommending timely follow-up and protocol steps for management at that facility or for transfer for further monitoring and management at a higher-level facility. The nurses participating in the study have been drawn from the health facilities themselves, in both control and intervention arms. Quantitative data will be collected on an ongoing basis through the mobile platform. Women are eligible for recruitment between 15 weeks and 36 weeks gestation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Study Start: 2019-08-31
• Primary Completion: 2020-04-01
• Study Completion: 2020-07-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

• at least 5 months pregnant

Exclusion Criteria

• Unable to provide consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Strengthened Referral Network from Community to Referral hospital levels	1. Community-based Pre-eclampsia/Eclampsia Detection and Management 2. Strengthened Referral Network from Community to Referral hospital levels 3. Antenatal Care Nurses will receive training on best practices for PE detection and management per Tanzanian Standard Treatment Guidelines. 4. Antenatal Care Nurses will be given smartphones and will be trained to complete Case Report Forms (CRF) to log key indicators and activities at each ANC visit, delivery and Postnatal Care visits of enrolled participants. 5. Antenatal Care Nurses will receive bluetooth blood pressure monitors. 6. Community Health Workers within the intervention arm facilities will receive training in pre-eclampsia features and will be provided with smart phones and access to a smart phone application that will prompt them to initiate follow ups with pregnant women within the community and they will receive SMS/text messages reminders about pregnant women within the community who require follow up.
Intervention Arm	Community-based Pre-eclampsia/Eclampsia Detection and Management	1. Community-based Pre-eclampsia/Eclampsia Detection and Management 2. Strengthened Referral Network from Community to Referral hospital levels 3. Antenatal Care Nurses will receive training on best practices for PE detection and management per Tanzanian Standard Treatment Guidelines. 4. Antenatal Care Nurses will be given smartphones and will be trained to complete Case Report Forms (CRF) to log key indicators and activities at each ANC visit, delivery and Postnatal Care visits of enrolled participants. 5. Antenatal Care Nurses will receive bluetooth blood pressure monitors. 6. Community Health Workers within the intervention arm facilities will receive training in pre-eclampsia features and will be provided with smart phones and access to a smart phone application that will prompt them to initiate follow ups with pregnant women within the community and they will receive SMS/text messages reminders about pregnant women within the community who require follow up.

Primary Outcome Measures

Name	Time	Method
Primary outcome (composite indicator reflecting activities associated with recognition and management/treatment of pre-eclampsia)	Outcome is evaluated at one month post delivery	A composite indicator reflecting activities (1) associated with recognition of pre-eclampsia by recognizing 1 of these 4 items; Blood pressure reading greater than 140 mmHg, Diastolic greater than 90 mmHg, Intrapatient BP rise of 30mmHg systolic or 15mmHg diastolic, Proteinuria (+) and headache, visual disturbance or both and/or epigastric pain and vomiting, or both, or edema and (2)activities associated with the management/treatment of pre-eclampsia.

Trial Locations

Locations (1)

Ifakara Health Institute; 🇹🇿 Dar es Salaam, Tanzania