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Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia

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ClinicalTrials.gov Identifier: NCT04058405
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Solwayo Ngwenya, Mpilo Central Hospital

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.

Condition or disease Intervention/treatment
Severe Preeclampsia 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.


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Study Type : Observational
Estimated Enrollment : 770 participants
Observational Model: Cohort
Time Perspective: Retrospective
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.
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Observational
    Cross-sectional observations
    Other Name: Studying


Primary Outcome Measures :
  1. Maternal death [ Time Frame: 3 years ]
    Binary outcomes



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cross-sectional all pregnant women with severe preeclampsia
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058405


Contacts
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Contact: SOLWAYO NGWENYA, FRCOG +263 9 214 965 ext 100 drsolngwe@yahoo.co.uk
Contact: ALEXANDER HEAZELL, PhD +44 161701 0889 alexander.heazell@manchester.ac.uk

Locations
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Zimbabwe
Mpilo Central Hospital Recruiting
Bulawayo, Matabeleland, Zimbabwe, +263
Contact: SOLWAYO NGWENYA, FRCOG    +263 9214 965    drsolngwe@yahoo.co.uk   
Sponsors and Collaborators
Mpilo Central Hospital

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Responsible Party: Solwayo Ngwenya, Director, Mpilo Central Hospital
ClinicalTrials.gov Identifier: NCT04058405     History of Changes
Other Study ID Numbers: MpiloCH
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications