Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia

Severe Preeclampsia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058405
• Other study ID #: MpiloCH
• Status: Completed
• Start date: November 12, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: Mpilo Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 549
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Severe Preeclampsia

Intervention

Behavioral:
• Observational
Cross-sectional observations

Locations

Country	Name	City	State
Zimbabwe	Mpilo Central Hospital	Bulawayo	Matabeleland

Sponsors (1)

Lead Sponsor	Collaborator
Mpilo Central Hospital

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal death	Binary outcomes	3 years