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

November 12, 2008
November 12, 2008
March 2002
July 2008   (final data collection date for primary outcome measure)
Progression to severe preeclampsia in the control group necessitating delivery of the infant. [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Mild Preeclampsia Near Term: Deliver or Deliberate?
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 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Preeclampsia
Procedure: Delivery of infant
Vaginal delivery or cesarean section, whichever is indicated
  • No Intervention: 1
    Study participants are admitted to hospital for standard inpatient management of their disease.
    Intervention: Procedure: Delivery of infant
  • Experimental: 2
    Study participants are admitted to hospital and their infant is delivered as soon as possible after 34 weeks' gestation.
    Intervention: Procedure: Delivery of infant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00789919
2001-1114
No
Michelle Y. Owens, M.D., Winfred L Wiser Hospital for Women and Infants
University of Mississippi Medical Center
Not Provided
Principal Investigator: Michelle Y Owens, M.D. University of Mississippi Medical Center
University of Mississippi Medical Center
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP