Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia

Mpilo Central Hospital

Status: Completed

Conditions: Severe Preeclampsia

Treatments: Behavioral: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT04058405

MpiloCH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 549 patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.