Clinical trial NCT04058405: Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Preeclampsia
Lead sponsor: Mpilo Central Hospital
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 549
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cross-sectional all pregnant women with severe preeclampsia

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal death
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bulawayo
country: Zimbabwe
facility: Mpilo Central Hospital
state: Matabeleland
Study officials:
affiliation: Mpilo Central Hospital
name: SOLWAYO NGWENYA, PhD, FRCOG
role: PRINCIPAL_INVESTIGATOR
References: