Clinical Trial: Mild Preeclampsia Near Term: Deliver or Deliberate?
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Mild Preeclampsia Near Term: Deliver or Deliberate?
Brief 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.
Detailed Summary:
Sponsor: University of Mississippi Medical Center
Current Primary Outcome: Progression to severe preeclampsia in the control group necessitating delivery of the infant. [ Time Frame: End of study ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Maternal morbidity [ Time Frame: End of study ]
- Fetal morbidity and mortality [ Time Frame: End of study ]
Original Secondary Outcome: Same as current
Information By: University of Mississippi Medical Center
Dates:
Date Received: November 12, 2008
Date Started: March 2002
Date Completion:
Last Updated: February 8, 2017
Last Verified: November 2008
