Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia

January 20, 2017 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Effects of Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia: A Randomized, Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

442

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama
        • Saint Thomas H
      • Panama, Panama
        • Saint Thomas Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Curettage
Postpartum uterine curettage performed immediately after delivery of the placenta.
Procedure: Curettage
Postpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta.
Placebo Comparator: Placebo
No procedure performed after delivery of the placenta.
Procedure: Placebo
No procedure after delivery of the placenta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic and diastolic blood pressure
Time Frame: 6 hours
Arterial blood pressure
6 hours
Systolic and diastolic blood pressure
Time Frame: 12 hours
Arterial blood pressure
12 hours
Systolic and diastolic blood pressure
Time Frame: 24 hours
Arterial blood pressure
24 hours
Systolic and diastolic blood pressure
Time Frame: 48 hours
Arterial Blood pressure
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Time Frame: 6 hours
Number of patients with an abnormal laboratory value
6 hours
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Time Frame: 12 hours
Number of patients with an abnormal laboratory value
12 hours
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Time Frame: 24 hours
Number of patients with an abnormal laboratory value
24 hours
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Time Frame: 48 hours
Number of patients with an abnormal laboratory value
48 hours
Seizures
Time Frame: 48 hours
Number of participants with the development of seizures after birth.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

December 11, 2016

Study Registration Dates

First Submitted

January 18, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHST2014-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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