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Trial record 58 of 276 for:    Panama

Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia

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ClinicalTrials.gov Identifier: NCT03028194
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., 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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Eclampsia Procedure: Curettage Procedure: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia: A Randomized, Controlled Trial
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : December 11, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

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




Primary Outcome Measures :
  1. Systolic and diastolic blood pressure [ Time Frame: 6 hours ]
    Arterial blood pressure

  2. Systolic and diastolic blood pressure [ Time Frame: 12 hours ]
    Arterial blood pressure

  3. Systolic and diastolic blood pressure [ Time Frame: 24 hours ]
    Arterial blood pressure

  4. Systolic and diastolic blood pressure [ Time Frame: 48 hours ]
    Arterial Blood pressure


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Seizures [ Time Frame: 48 hours ]
    Number of participants with the development of seizures after birth.



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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028194


Locations
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Panama
Saint Thomas H
Panama, Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
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Study Chair: Osvaldo Reyes, MD Saint Thomas Hospital, Panama

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Responsible Party: Osvaldo A. Reyes T., Head of the Research Department, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT03028194     History of Changes
Other Study ID Numbers: MHST2014-06
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Pre-eclampsia
Eclampsia
Postpartum uterine curettage

Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications