Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia

Completed

• Conditions: Severe Preeclampsia

• Registration Number: NCT04058405
• Lead Sponsor: Mpilo Central Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-11-12
• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 549

Inclusion Criteria

• Participants will be included in the study if they have a diagnosis of severe preeclampsia.
• Severe preeclampsia will be defined as high blood pressure (systolic blood pressure (SBP) ≥160, diastolic blood pressure(DBP) ≥110mmHg) and or either severe headaches, epigastric pains and deranged biochemical/haematological blood indices.
• Both singleton and twin/higher order pregnancies will be included.

Exclusion Criteria

-Women with mild or moderate preeclampsia or less than 20 weeks' of gestation and those with epilepsy will be excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal death	3 years	Binary outcomes

Trial Locations

Locations (1)

Mpilo Central Hospital; 🇿🇼 Bulawayo, Matabeleland, Zimbabwe