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NCT00789919 · ClinicalTrials.gov registry record · NA
Mild Preeclampsia Near Term: Deliver or Deliberate?
A NA study, sponsored by University of Mississippi Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 185
- Enrollment target
NCT00789919 is a NA study that has completed, run by University of Mississippi Medical Center. The registered enrollment target is 185 participants.
The verdict
NCT00789919, a NA study, has completed, sponsored by University of Mississippi Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 185 participants
- Enrollment target
Study Summary
Preeclampsia with new-onset hypertension and proteinuria is a pregnancy-specific disease that affects 5-7% of gestations usually after the 20th week. Most cases are mild, but severe cases exhibit multiple abnormalities in blood and maternal organ systems. Severe forms of preeclampsia/eclampsia are a major contributor to maternal death in the world. Delivery stops disease progression and recovery can begin. Patients with mild preeclampsia between 34-38 weeks' gestation usually are hospitalized for evaluation and close monitoring of signs, symptoms, and certain laboratory studies as reflectors of disease status. As inpatients mothers are monitored frequently for evidence of maternal or fetal compromise until 38 weeks gestation when delivery is accomplished. If a patient with mild preeclampsia labors after 34 weeks, no attempt is made to stop labor and delivery is undertaken. It remains unclear when during the third trimester that delivery should be accomplished for maximal maternal safety and minimal fetal risk. In this research project, we will identify patients who are at least 34 weeks pregnant with mild preeclampsia. After informed consent to participate in the trial, we will randomize participants to either be delivered immediately or treated with observation and maternal-fetal surveillance in hospital as described previously with delivery at 38 weeks. There will be 110 participants enrolled in each arm of the study for a total of 220 patients who will be managed in the Wiser Hospital. We intend to analyze a number of maternal and fetal outcomes including cost comparisons for the care of both mother and fetus in the two groups of randomized patients. The findings should impact care of the pregnant patient with mild preeclampsia in the third trimester with regard to how early and how late in gestation that delivery should be accomplished for optimal maternal and perinatal benefit.
Interventions
- PROCEDURE Delivery of infant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2002-03 |
| Est. Completion | 2008-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00789919
The ClinicalTrials.gov registry entry for NCT00789919 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 185 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Mississippi Medical Center, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Delivery of infant is the first listed.
NCT00789919 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00789919 about?
NCT00789919 is a clinical study titled "Mild Preeclampsia Near Term: Deliver or Deliberate?". Preeclampsia with new-onset hypertension and proteinuria is a pregnancy-specific disease that affects 5-7% of gestations usually after the 20th week. Most cases are mild, but severe cases exhibit multiple abnormalities in blood and maternal organ systems. Severe forms of preeclampsia/eclampsia are a...
What is the current status of trial NCT00789919?
This trial is currently completed. It is a NA study. The enrollment target is 185 participants. The study started on 2002-03. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00789919?
The interventions under investigation include: Delivery of infant (PROCEDURE).
Who is sponsoring clinical trial NCT00789919?
This trial is sponsored by University of Mississippi Medical Center, which has 96 total clinical trials registered on ClinicalTrials.gov.
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