Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028194
• Other study ID #: MHST2014-06
• Status: Completed
• Phase: N/A
• First received: January 18, 2017
• Last updated: January 20, 2017
• Start date: October 1, 2015
• Est. completion date: December 11, 2016

Study information

• Verified date: January 2017
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: December 11, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

• Gestational age 24 weeks or more.

• Preeclampsia/eclampsia

Exclusion Criteria:

• Epilepsy or seizures previous to pregnancy.

• Renal disease

• Heart disease

• Liver disease

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Procedure:
• Curettage
Postpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta.
• Placebo
No procedure after delivery of the placenta

Locations

Country	Name	City	State
Panama	Saint Thomas H	Panama
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic and diastolic blood pressure	Arterial blood pressure	6 hours
Primary	Systolic and diastolic blood pressure	Arterial blood pressure	12 hours
Primary	Systolic and diastolic blood pressure	Arterial blood pressure	24 hours
Primary	Systolic and diastolic blood pressure	Arterial Blood pressure	48 hours
Secondary	Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).	Number of patients with an abnormal laboratory value	6 hours
Secondary	Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).	Number of patients with an abnormal laboratory value	12 hours
Secondary	Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).	Number of patients with an abnormal laboratory value	24 hours
Secondary	Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).	Number of patients with an abnormal laboratory value	48 hours
Secondary	Seizures	Number of participants with the development of seizures after birth.	48 hours