Mild Preeclampsia Near Term: Deliver or Deliberate?

NCT00789919 | Completed

• 1 other identifier: 2001-1114
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Keywords

Mild Preeclampsia

Outcome Measures

Primary Outcomes (1)

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

  End of study

Secondary Outcomes (2)

• Maternal morbidity

  End of study

• Fetal morbidity and mortality

  End of study

Study Arms (2)

1

NO INTERVENTION

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

2

EXPERIMENTAL

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

Interventions

Delivery of infant PROCEDURE

Vaginal delivery or cesarean section, whichever is indicated

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

Winfred L Wiser Hospital for Women and Infants

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Michelle Y Owens, M.D.

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 13, 2008
• Study Start: March 1, 2002
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 10, 2017

Record last verified: 2008-11

Locations

US (1)