Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia

Study Overview
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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.

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

Conditions
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Pre-Eclampsia, Eclampsia

Intervention / Treatment
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* Procedure: Curettage
* Procedure: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-eclampsia, Eclampsia, Postpartum uterine curettage