Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia

Not Applicable

Completed

• Conditions: Eclampsia; Pre-Eclampsia
• Interventions: Procedure: Placebo; Procedure: Curettage

• Registration Number: NCT03028194
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief Summary

Use of Postpartum uterine curettage in reducing hospitalization time or in improving the clinical evolution of the patient with preeclampsia/eclampsia.

Detailed Description

To evaluate if postpartum uterine curettage improved the clinical and laboratory parameters in patients with preeclampsia or eclampsia.

A total of 442 patients with preeclampsia/eclampsia were randomized to postpartum curettage (223) or no procedure (219). Systolic and diastolic blood pressure were recorded and analyzed at hours 6, 12, 24 and 48. Also, several laboratory values and diuresis were evaluated.

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2016-10-31
• Study Completion: 2016-12-11
• Status Verified: 2017-01
• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-01-20
• Last Update Submitted: 2017-01-20
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 442

Inclusion Criteria

• Gestational age 24 weeks or more.
• Preeclampsia/eclampsia

Exclusion Criteria

• Epilepsy or seizures previous to pregnancy.
• Renal disease
• Heart disease
• Liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	No procedure performed after delivery of the placenta.
Curettage	Curettage	Postpartum uterine curettage performed immediately after delivery of the placenta.

Primary Outcome Measures

Name	Time	Method
Systolic and diastolic blood pressure	48 hours	Arterial Blood pressure

Secondary Outcome Measures

Name	Time	Method
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).	48 hours	Number of patients with an abnormal laboratory value
Seizures	48 hours	Number of participants with the development of seizures after birth.

Trial Locations

Locations (2)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama

Saint Thomas H; 🇵🇦 Panama, Panama