Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia

Statistical Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Severe Preeclampsia in a Low-resource Setting, Mpilo Central Hospital, Bulawayo, 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.

Study Overview

• Status: Completed
• Conditions: Severe Preeclampsia
• Intervention / Treatment: Behavioral: Observational

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 Type: Observational
• Enrollment (Actual): 549

Contacts and Locations

Study Locations

• Zimbabwe
  • Matabeleland
    • Bulawayo, Matabeleland, Zimbabwe, +263
      • Mpilo Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Cross-sectional all pregnant women with severe preeclampsia

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal death	Binary outcomes	3 years

Collaborators and Investigators

• Sponsor: Mpilo Central Hospital
• Investigators: Principal Investigator: SOLWAYO NGWENYA, PhD, FRCOG, Mpilo Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: MpiloCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Currently the data is under a university

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No