Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia

NCT ID: NCT04058405

Last Updated: 2021-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

549 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-12

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Severe Preeclampsia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Observational

Cross-sectional observations

Intervention Type BEHAVIORAL

Other Intervention Names

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Studying

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mpilo Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Solwayo Ngwenya

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SOLWAYO NGWENYA, PhD, FRCOG

Role: PRINCIPAL_INVESTIGATOR

Mpilo Central Hospital

Locations

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Mpilo Central Hospital

Bulawayo, Matabeleland, Zimbabwe

Site Status

Countries

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Zimbabwe

Other Identifiers

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MpiloCH

Identifier Type: -

Identifier Source: org_study_id

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