Mild Preeclampsia Near Term: Deliver or Deliberate?

This study has been completed.
Sponsor:
Information provided by:
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00789919
First received: November 12, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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 Intervention
Preeclampsia
Procedure: Delivery of infant

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mild Preeclampsia Near Term: Deliver or Deliberate?

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Progression to severe preeclampsia in the control group necessitating delivery of the infant. [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maternal morbidity [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
  • Fetal morbidity and mortality [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Enrollment: 185
Study Start Date: March 2002
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Study participants are admitted to hospital for standard inpatient management of their disease.
Procedure: Delivery of infant
Vaginal delivery or cesarean section, whichever is indicated
Experimental: 2
Study participants are admitted to hospital and their infant is delivered as soon as possible after 34 weeks' gestation.
Procedure: Delivery of infant
Vaginal delivery or cesarean section, whichever is indicated

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789919

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

No publications provided

Responsible Party: Michelle Y. Owens, M.D., Winfred L Wiser Hospital for Women and Infants
ClinicalTrials.gov Identifier: NCT00789919     History of Changes
Other Study ID Numbers: 2001-1114
Study First Received: November 12, 2008
Last Updated: November 12, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Mild Preeclampsia

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on October 30, 2014