NCT04058405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
549

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

August 6, 2019

Last Update Submit

September 2, 2021

Conditions

Severe Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • Maternal death

    Binary outcomes

    3 years

Interventions

ObservationalBEHAVIORAL

Cross-sectional observations

Also known as: Studying

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cross-sectional all pregnant women with severe preeclampsia

You may qualify if:

  • 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.

You may not qualify if:

  • Women with mild or moderate preeclampsia or less than 20 weeks' of gestation and those with epilepsy will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mpilo Central Hospital

Bulawayo, Matabeleland, +263, Zimbabwe

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • SOLWAYO NGWENYA, PhD, FRCOG

    Mpilo Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 15, 2019

Study Start

November 12, 2018

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

ZI(1)