Pre-EclampsiaNCT03978429
An mHealth Strategy to Reduce Pre-Eclampsia and Infant Death in Tanzania
A study testing Community-based Pre-eclampsia/Eclampsia Detection and Management and Strengthened Referral Network from Community to Referral hospital levels in people with Pre-Eclampsia and Eclampsia, run by Dr. Karen Yeates at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Eclampsia, Hypertension, Pregnancy-Induced
- What is being tested?
- Community-based Pre-eclampsia/Eclampsia Detection and Management and Strengthened Referral Network from Community to Referral hospital levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteTanzania
- Study dates
- 31 Aug 2019to 1 Jul 2020
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 5 months pregnant
Who cannot join
- Unable to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized, Parallel-group, Superiority Study to Compare the Effectiveness of a Community-based mHealth Strategy Versus Enhanced Usual Care in the Detection and Management of Pre-eclampsia/Eclampsia in Tanzania
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.
- Conditions
- Pre-Eclampsia, Eclampsia, Hypertension, Pregnancy-Induced
- Being tested
- Community-based Pre-eclampsia/Eclampsia Detection and Management, Strengthened Referral Network from Community to Referral hospital levels
- Keywords
- Pre-eclampsia, Eclampsia, mHealth, mobile health, Gestosis, Hypertension, Pregnancy-Induced
- Medical subject headings
- Pre-Eclampsia, Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based Pre-eclampsia/Eclampsia Detection and ManagementOther
Three Community Health Workers (CHWs) per health facility (cluster) will be equipped with android smartphones and blood pressure monitors. The CHWs will visit participant's home once per month until 6 weeks post-partum and complete a Case Report Form for signs and symptoms of pre-eclampsia and blood pressure. CHWs, Antenatal Care Nurses (ANC) at the woman's health facility and study coordinator will receive SMS message if the algorithm on our platform (informed by the Tanzanian Standard Treatment Guidelines (TSTG) deems she is at risk for pre-eclampsia. This message will indicate that the woman needs to be referred to her health facility if: participant has high blood pressure, a significant intrapatient rise in blood pressure or a combination of factors according to an algorithm. Woman's condition will be assessed and ANC will decide on the management, including rest at home with CHW monitoring. Women found to be at risk for pre-eclampsia will be visited twice monthly.
Strengthened Referral Network from Community to Referral hospital levelsOther
ANC nurses and CHWs will play complementary roles in performing activities to meet key indicators and facilitate referrals. They will deliver a plan using the Pre-eclampsia application tool on their smart phone and then they can refer the pregnant woman for enrollment for facility care and track them as per key indicators. The key innovation is that the mHealth platform can detect increases in BP within each patient, and this ability to detect is brought down to the community level through CHWs. This will allow for earlier detection of PE as singular BPs. Nurses will receive protocolized instructions and education regarding when to refer a woman to a higher-level facility for further management. The program consists of SMS component delivered to provide information about participant's condition to relevant members of the referral pathway to enhance referrals and facilitate community level follow up.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Other: Community-based Pre-eclampsia/Eclampsia Detection and Management; Other: Strengthened Referral Network from Community to Referral hospital levels |
| Enhanced Usual Care | No intervention | 1. Antenatal Care Nurses will receive training on best practices for PE detection and management per Tanzanian Standard Treatment Guidelines. 2. 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. 3. Antenatal Care Nurses will receive bluetooth blood pressure monitors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome (composite indicator reflecting activities associated with recognition and management/treatment of pre-eclampsia)
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.
Measured: Outcome is evaluated at one month post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start31 Aug 2019
- Primary completion1 Apr 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Karen Yeates
- Sponsor type
- University, hospital or other
- Collaborators
- Ifakara Health Institute
- Responsible party
- Sponsor-investigator, Dr. Karen Yeates, Queen's University
- Investigators
- Karen E Yeates, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978429
- Sponsor's protocol ID
- 108022
- Status last verified
- Dec 2023
- First submitted
- 5 Jun 2019
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
National Bureau of Statistics,. Tanzania Demographic and Health Survey (TDHS-MIS) 2010. (MoHCDGEC, MoH, NBS, OCGS, and ICF, 2010).
Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC) [Tanzania, Mainland], Ministry of Health (MoH) [Zanzibar], National Bureau of Statistics (NBS), Office of the Chief & Government Statistician (OCGS), and ICF. Tanzania Demographic and Health Survey and Malaria Indicator Survey (TDHS-MIS) 2015-16. (MoHCDGEC, MoH, NBS, OCGS, and ICF, 2016).
The National Republic of Tanzania Ministry of Health, Community Development, Gender, Elderly and Children. Standard Treatment Guidelines & National Essential Medicines List. Fifth Edition. (2017).
Maar MA, Yeates K, Toth Z, Barron M, Boesch L, Hua-Stewart D, Liu P, Perkins N, Sleeth J, Wabano MJ, Williamson P, Tobe SW. Unpacking the Black Box: A Formative Research Approach to the Development of Theory-Driven, Evidence-Based, and Culturally Safe Text Messages in Mobile Health Interventions. JMIR Mhealth Uhealth. 2016 Jan 22;4(1):e10. doi: 10.2196/mhealth.4994.
PubMed 26800712Rosenstock, I. M. The Health Belief Model and Preventive Health Behavior. Health Educ. Behav. 2, 354-386 (1974).
Jennings L, Gagliardi L. Influence of mHealth interventions on gender relations in developing countries: a systematic literature review. Int J Equity Health. 2013 Oct 16;12:85. doi: 10.1186/1475-9276-12-85.
PubMed 24131553Research in Gender and Ethics (RinGs). mHealth and Gender: Making the Connection. (2015).
Nie J, Unger JA, Thompson S, Hofstee M, Gu J, Mercer MA. Does mobile phone ownership predict better utilization of maternal and newborn health services? a cross-sectional study in Timor-Leste. BMC Pregnancy Childbirth. 2016 Jul 23;16(1):183. doi: 10.1186/s12884-016-0981-1.
PubMed 27448798GSMA Intelligence. Bridging the gender gap: Mobile access and usage in low- and middle-income countries. (2016).
GSMA Intelligence. Women and Mobile: A Global Opportunity.
Wesolowski A, Eagle N, Noor AM, Snow RW, Buckee CO. Heterogeneous mobile phone ownership and usage patterns in Kenya. PLoS One. 2012;7(4):e35319. doi: 10.1371/journal.pone.0035319. Epub 2012 Apr 25.
PubMed 22558140Blumenstock, J. & Eagle, N. Mobile divides: gender, socioeconomic status, and mobile phone use in Rwanda. in Proceedings of the 4th ACM/IEEE International Conference on Information and Communication Technologies and Development 6 (ACM, 2010).
GSMA mWomen. Striving and Surviving: Exploring the Lives of Women at the Base of the Pyramid. 1-74 (2012).
Chib A, Wilkin H, Ling LX, Hoefman B, Van Biejma H. You have an important message! Evaluating the effectiveness of a text message HIV/AIDS campaign in Northwest Uganda. J Health Commun. 2012;17 Suppl 1:146-57. doi: 10.1080/10810730.2011.649104.
PubMed 22548607Siedner MJ, Santorino D, Haberer JE, Bangsberg DR. Know your audience: predictors of success for a patient-centered texting app to augment linkage to HIV care in rural Uganda. J Med Internet Res. 2015 Mar 24;17(3):e78. doi: 10.2196/jmir.3859.
PubMed 25831269
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized, Parallel-group, Superiority Study to Compare the Effectiveness of a Community-based mHealth Strategy Versus Enhanced Usual Care in the Detection and Management of Pre-eclampsia/Eclampsia in Tanzania
- ClinicalTrials.gov ID
- NCT03978429
- Acronym / sponsor ID
- 108022
- Conditions
- Pre-Eclampsia, Eclampsia, Hypertension, Pregnancy-Induced
- Keywords
- Pre-eclampsia, Eclampsia, mHealth, mobile health, Gestosis, Hypertension, Pregnancy-Induced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Dr. Karen YeatesUniversity, hospital or other
- Collaborators
- Ifakara Health Institute
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 7 Jun 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Community-based Pre-eclampsia/Eclampsia Detection and Management, Other: Strengthened Referral Network from Community to Referral hospital levels1. 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. |
| Enhanced Usual Care | No intervention | –1. Antenatal Care Nurses will receive training on best practices for PE detection and management per Tanzanian Standard Treatment Guidelines. 2. 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. 3. Antenatal Care Nurses will receive bluetooth blood pressure monitors. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- at least 5 months pregnant
Key exclusion criteria (1 listed)
- Unable to provide consent.
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-based Pre-eclampsia/Eclampsia Detection and ManagementThree Community Health Workers (CHWs) per health facility (cluster) will be equipped with android smartphones and blood pressure monitors. The CHWs will visit participant's home once per month until 6 weeks post-partum and complete a Case Report Form for signs and symptoms of pre-eclampsia and blood pressure. CHWs, Antenatal Care Nurses (ANC) at the woman's health facility and study coordinator will receive SMS message if the algorithm on our platform (informed by the Tanzanian Standard Treatment Guidelines (TSTG) deems she is at risk for pre-eclampsia. This message will indicate that the woman needs to be referred to her health facility if: participant has high blood pressure, a significant intrapatient rise in blood pressure or a combination of factors according to an algorithm. Woman's condition will be assessed and ANC will decide on the management, including rest at home with CHW monitoring. Women found to be at risk for pre-eclampsia will be visited twice monthly. | Other | Intervention Arm |
| Strengthened Referral Network from Community to Referral hospital levelsANC nurses and CHWs will play complementary roles in performing activities to meet key indicators and facilitate referrals. They will deliver a plan using the Pre-eclampsia application tool on their smart phone and then they can refer the pregnant woman for enrollment for facility care and track them as per key indicators. The key innovation is that the mHealth platform can detect increases in BP within each patient, and this ability to detect is brought down to the community level through CHWs. This will allow for earlier detection of PE as singular BPs. Nurses will receive protocolized instructions and education regarding when to refer a woman to a higher-level facility for further management. The program consists of SMS component delivered to provide information about participant's condition to relevant members of the referral pathway to enhance referrals and facilitate community level follow up. | Other | Intervention Arm |
Primary outcome
Primary outcome (composite indicator reflecting activities associated with recognition and management/treatment of pre-eclampsia)
Time frame: 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.
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 26 Dec 2023.
- BackgroundNational Bureau of Statistics,. Tanzania Demographic and Health Survey (TDHS-MIS) 2010. (MoHCDGEC, MoH, NBS, OCGS, and ICF, 2010).
- BackgroundMinistry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC) [Tanzania, Mainland], Ministry of Health (MoH) [Zanzibar], National Bureau of Statistics (NBS), Office of the Chief & Government Statistician (OCGS), and ICF. Tanzania Demographic and Health Survey and Malaria Indicator Survey (TDHS-MIS) 2015-16. (MoHCDGEC, MoH, NBS, OCGS, and ICF, 2016).
- BackgroundThe National Republic of Tanzania Ministry of Health, Community Development, Gender, Elderly and Children. Standard Treatment Guidelines & National Essential Medicines List. Fifth Edition. (2017).
- Background: PubMed 26800712Maar MA, Yeates K, Toth Z, Barron M, Boesch L, Hua-Stewart D, Liu P, Perkins N, Sleeth J, Wabano MJ, Williamson P, Tobe SW. Unpacking the Black Box: A Formative Research Approach to the Development of Theory-Driven, Evidence-Based, and Culturally Safe Text Messages in Mobile Health Interventions. JMIR Mhealth Uhealth. 2016 Jan 22;4(1):e10. doi: 10.2196/mhealth.4994.
- BackgroundRosenstock, I. M. The Health Belief Model and Preventive Health Behavior. Health Educ. Behav. 2, 354-386 (1974).
- Background: PubMed 24131553Jennings L, Gagliardi L. Influence of mHealth interventions on gender relations in developing countries: a systematic literature review. Int J Equity Health. 2013 Oct 16;12:85. doi: 10.1186/1475-9276-12-85.
- BackgroundResearch in Gender and Ethics (RinGs). mHealth and Gender: Making the Connection. (2015).
- Background: PubMed 27448798Nie J, Unger JA, Thompson S, Hofstee M, Gu J, Mercer MA. Does mobile phone ownership predict better utilization of maternal and newborn health services? a cross-sectional study in Timor-Leste. BMC Pregnancy Childbirth. 2016 Jul 23;16(1):183. doi: 10.1186/s12884-016-0981-1.
- BackgroundGSMA Intelligence. Bridging the gender gap: Mobile access and usage in low- and middle-income countries. (2016).
- BackgroundGSMA Intelligence. Women and Mobile: A Global Opportunity.
- Background: PubMed 22558140Wesolowski A, Eagle N, Noor AM, Snow RW, Buckee CO. Heterogeneous mobile phone ownership and usage patterns in Kenya. PLoS One. 2012;7(4):e35319. doi: 10.1371/journal.pone.0035319. Epub 2012 Apr 25.
- BackgroundBlumenstock, J. & Eagle, N. Mobile divides: gender, socioeconomic status, and mobile phone use in Rwanda. in Proceedings of the 4th ACM/IEEE International Conference on Information and Communication Technologies and Development 6 (ACM, 2010).
- Individual participant dataSharing planned: No
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Karen E Yeates, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based Pre-eclampsia/Eclampsia Detection and Management and Strengthened Referral Network from Community to Referral hospital levels in people with Pre-Eclampsia and Eclampsia, run by Dr. Karen Yeates at 1 site in Tanzania.
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 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. 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?
Primary outcome (composite indicator reflecting activities associated with recognition and management/treatment of pre-eclampsia) (time frame: Outcome is evaluated at one month post delivery). 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 NCT03978429, which also lists 17 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 26 Dec 2023.