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Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia

Primary Purpose

Pre-Eclampsia, Eclampsia

Status
Completed
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
Curettage
Placebo
Sponsored by
Saint Thomas Hospital, Panama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-Eclampsia focused on measuring Pre-eclampsia, Eclampsia, Postpartum uterine curettage

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Saint Thomas H
  • Saint Thomas Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Curettage

Placebo

Arm Description

Postpartum uterine curettage performed immediately after delivery of the placenta.

No procedure performed after delivery of the placenta.

Outcomes

Primary Outcome Measures

Systolic and diastolic blood pressure
Arterial blood pressure
Systolic and diastolic blood pressure
Arterial blood pressure
Systolic and diastolic blood pressure
Arterial blood pressure
Systolic and diastolic blood pressure
Arterial Blood pressure

Secondary Outcome Measures

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

Full Information

First Posted
January 18, 2017
Last Updated
January 20, 2017
Sponsor
Saint Thomas Hospital, Panama
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1. Study Identification

Unique Protocol Identification Number
NCT03028194
Brief Title
Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia
Official Title
Effects of Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
October 31, 2016 (Actual)
Study Completion Date
December 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Eclampsia
Keywords
Pre-eclampsia, Eclampsia, Postpartum uterine curettage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
442 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Curettage
Arm Type
Experimental
Arm Description
Postpartum uterine curettage performed immediately after delivery of the placenta.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
No procedure performed after delivery of the placenta.
Intervention Type
Procedure
Intervention Name(s)
Curettage
Intervention Description
Postpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta.
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
No procedure after delivery of the placenta
Primary Outcome Measure Information:
Title
Systolic and diastolic blood pressure
Description
Arterial blood pressure
Time Frame
6 hours
Title
Systolic and diastolic blood pressure
Description
Arterial blood pressure
Time Frame
12 hours
Title
Systolic and diastolic blood pressure
Description
Arterial blood pressure
Time Frame
24 hours
Title
Systolic and diastolic blood pressure
Description
Arterial Blood pressure
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Description
Number of patients with an abnormal laboratory value
Time Frame
6 hours
Title
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Description
Number of patients with an abnormal laboratory value
Time Frame
12 hours
Title
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Description
Number of patients with an abnormal laboratory value
Time Frame
24 hours
Title
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Description
Number of patients with an abnormal laboratory value
Time Frame
48 hours
Title
Seizures
Description
Number of participants with the development of seizures after birth.
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age 24 weeks or more. Preeclampsia/eclampsia Exclusion Criteria: Epilepsy or seizures previous to pregnancy. Renal disease Heart disease Liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osvaldo Reyes, MD
Organizational Affiliation
Saint Thomas Hospital, Panama
Official's Role
Study Chair
Facility Information:
Facility Name
Saint Thomas H
City
Panama
Country
Panama
Facility Name
Saint Thomas Maternity Hospital
City
Panama
Country
Panama

12. IPD Sharing Statement

Plan to Share IPD
No

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Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia

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