Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04058405|
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment|
|Severe Preeclampsia||Behavioral: Observational|
Hypertensive disorders in pregnancy are a leading cause of maternal and perinatal morbidity and mortality, especially in low-resource settings. Identifying mothers and babies at greatest risk of complications would enable intervention to be targeted to those most likely to benefit from them. However, current risk prediction models have a wide range of sensitivity (42-81%) and specificity (87-92%) indicating that improvements are needed. Furthermore, no predictive models have been developed or evaluated in Zimbabwe.
This proposal describes a single centre retrospective cross-sectional study which will address the need to further develop and test statistical risk prediction models for adverse maternal and neonatal outcomes in low-resource settings; this will be the first such research to be carried out in Zimbabwe.
Data will be collected on maternal demographics characteristics, outcome of prior pregnancies, past medical history, symptoms and signs on admission, results of biochemical and haematological investigations. Adverse outcome will be defined as a composite of maternal morbidity and mortality and perinatal morbidity and mortality. Association between variables and outcomes will be explored using multivariable logistic regression.
Critically, new risk prediction models introduced for our clinical setting may reduce avoidable maternal and neonatal morbidity and mortality at local, national, regional and international level.
|Study Type :||Observational|
|Estimated Enrollment :||770 participants|
|Official Title:||Statistical Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Severe Preeclampsia in a Low-resource Setting, Mpilo Central Hospital, Bulawayo, Zimbabwe.|
|Actual Study Start Date :||November 12, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2024|
- Behavioral: Observational
Cross-sectional observationsOther Name: Studying
- Maternal death [ Time Frame: 3 years ]Binary outcomes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058405
|Contact: SOLWAYO NGWENYA, FRCOG||+263 9 214 965 ext email@example.com|
|Contact: ALEXANDER HEAZELL, PhD||+44 161701 firstname.lastname@example.org|
|Mpilo Central Hospital||Recruiting|
|Bulawayo, Matabeleland, Zimbabwe, +263|
|Contact: SOLWAYO NGWENYA, FRCOG +263 9214 965 email@example.com|