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Trial record 10 of 120 for:    severe preeclampsia AND delivery

Mild Preeclampsia Near Term: Deliver or Deliberate?

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. Read our disclaimer for details. Identifier: NCT00789919
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
University of Mississippi Medical Center

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.

Condition or disease Intervention/treatment Phase
Preeclampsia Procedure: Delivery of infant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mild Preeclampsia Near Term: Deliver or Deliberate?
Study Start Date : March 2002
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: 1
Study participants (those diagnosed with mild preeclampsia) are admitted to hospital for standard inpatient management of their disease.
Experimental: 2
Study participants (those diagnosed with mild preeclampsia) are admitted to hospital and their infant is delivered as soon as possible after 34 weeks gestation. As there is no determined optimal time of delivery in these patients, delivery is the intervention.
Procedure: Delivery of infant
Vaginal delivery or cesarean section, whichever is indicated

Primary Outcome Measures :
  1. Progression to severe preeclampsia in the control group necessitating delivery of the infant. [ Time Frame: End of study ]

Secondary Outcome Measures :
  1. Maternal morbidity [ Time Frame: End of study ]
  2. Fetal morbidity and mortality [ Time Frame: End of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mild Preeclampsia equal to or greater than 34 weeks' and less that 38 weeks' gestation singleton gestation no maternal or fetal contraindications to conservative management

Exclusion Criteria:

  • Non-gestational diabetes Chronic hypertension Severe preeclampsia Non-reassuring fetal assessment intrauterine growth restriction fetal anomalies multiple gestation premature preterm rupture of membranes placenta previa unexplained vaginal bleeding antihypertensive use current gestation poor dating criteria contraindication to conservative management active labor at admission

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 identifier (NCT number): NCT00789919

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United States, Mississippi
Winfred L Wiser Hospital for Women and Infants
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
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Principal Investigator: Michelle Y Owens, M.D. University of Mississippi Medical Center

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Responsible Party: University of Mississippi Medical Center Identifier: NCT00789919     History of Changes
Other Study ID Numbers: 2001-1114
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: November 2008
Keywords provided by University of Mississippi Medical Center:
Mild Preeclampsia
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Pregnancy Complications