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Mild Preeclampsia Near Term: Deliver or Deliberate?

Primary Purpose

Preeclampsia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delivery of infant
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia focused on measuring Mild Preeclampsia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Winfred L Wiser Hospital for Women and Infants

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

Study participants (those diagnosed with mild preeclampsia) are admitted to hospital for standard inpatient management of their disease.

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.

Outcomes

Primary Outcome Measures

Progression to severe preeclampsia in the control group necessitating delivery of the infant.

Secondary Outcome Measures

Maternal morbidity
Fetal morbidity and mortality

Full Information

First Posted
November 12, 2008
Last Updated
February 8, 2017
Sponsor
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00789919
Brief Title
Mild Preeclampsia Near Term: Deliver or Deliberate?
Official Title
Mild Preeclampsia Near Term: Deliver or Deliberate?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Mild Preeclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Study participants (those diagnosed with mild preeclampsia) are admitted to hospital for standard inpatient management of their disease.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Delivery of infant
Intervention Description
Vaginal delivery or cesarean section, whichever is indicated
Primary Outcome Measure Information:
Title
Progression to severe preeclampsia in the control group necessitating delivery of the infant.
Time Frame
End of study
Secondary Outcome Measure Information:
Title
Maternal morbidity
Time Frame
End of study
Title
Fetal morbidity and mortality
Time Frame
End of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Y Owens, M.D.
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winfred L Wiser Hospital for Women and Infants
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

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Mild Preeclampsia Near Term: Deliver or Deliberate?

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