NCT03028194

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
442

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

January 18, 2017

Last Update Submit

January 20, 2017

Conditions

Pre-EclampsiaEclampsia

Keywords

Pre-eclampsiaEclampsiaPostpartum uterine curettage

Outcome Measures

Primary Outcomes (4)

  • Systolic and diastolic blood pressure

    Arterial blood pressure

    6 hours

  • Systolic and diastolic blood pressure

    Arterial blood pressure

    12 hours

  • Systolic and diastolic blood pressure

    Arterial blood pressure

    24 hours

  • Systolic and diastolic blood pressure

    Arterial Blood pressure

    48 hours

Secondary Outcomes (5)

  • Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).

    6 hours

  • Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).

    12 hours

  • Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).

    24 hours

  • Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).

    48 hours

  • Seizures

    48 hours

Study Arms (2)

Curettage

EXPERIMENTAL

Postpartum uterine curettage performed immediately after delivery of the placenta.

Procedure: Curettage

Placebo

PLACEBO COMPARATOR

No procedure performed after delivery of the placenta.

Procedure: Placebo

Interventions

CurettagePROCEDURE

Postpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta.

Curettage
PlaceboPROCEDURE

No procedure after delivery of the placenta

Placebo

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint Thomas H

Panama City, Provincia de Panamá, Panama

Location

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Conditions

Pre-EclampsiaEclampsia

Interventions

Curettage

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Osvaldo Reyes, MD

    Saint Thomas Hospital, Panama

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Research Department

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 23, 2017

Study Start

October 1, 2015

Primary Completion

October 31, 2016

Study Completion

December 11, 2016

Last Updated

January 23, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)