Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia

NCT ID: NCT03028194

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2016-12-11

Brief Summary

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

Detailed Description

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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.

Conditions

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Pre-Eclampsia Eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Curettage

Postpartum uterine curettage performed immediately after delivery of the placenta.

Group Type EXPERIMENTAL

Curettage

Intervention Type PROCEDURE

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

Placebo

No procedure performed after delivery of the placenta.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

No procedure after delivery of the placenta

Interventions

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Curettage

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

Intervention Type PROCEDURE

Placebo

No procedure after delivery of the placenta

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Epilepsy or seizures previous to pregnancy.
* Renal disease
* Heart disease
* Liver disease
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Head of the Research Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osvaldo Reyes, MD

Role: STUDY_CHAIR

Saint Thomas Hospital, Panama

Locations

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Saint Thomas H

Panama City, Provincia de Panamá, Panama

Site Status

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Site Status

Countries

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Panama

Other Identifiers

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MHST2014-06

Identifier Type: -

Identifier Source: org_study_id

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