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Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 6, 2019
First Posted Date August 15, 2019
Last Update Posted Date August 15, 2019
Actual Study Start Date November 12, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2019)
Maternal death [ Time Frame: 3 years ]
Binary outcomes
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Cross-sectional all pregnant women with severe preeclampsia
Condition Severe Preeclampsia
Intervention Behavioral: Observational
Cross-sectional observations
Other Name: Studying
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 14, 2019)
770
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: Female
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Zimbabwe
Removed Location Countries  
 
Administrative Information
NCT Number NCT04058405
Other Study ID Numbers MpiloCH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Solwayo Ngwenya, Mpilo Central Hospital
Study Sponsor Mpilo Central Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Mpilo Central Hospital
Verification Date August 2019