Protocol summary

Summary
Objectives : This investigation was undertaken to estimate whether postpartum oral furosemide for patients with severe preeclampsia benefits recovery and shortens hospitalization by enhancing diuresis , lessening severe hypertension and reducing the need for antihypertensive therapy. Inclusion criteria: patients delivered of a pregnancy at or grater than 20 weeks of gestation and diagnosed with severe preeclampsia. Exclusion criteria:patients who had hypokalemia ( serum potassium less than 3 meq/l) on admission; were already taking diuretic or potassium supplements for any reason; demonstrated any hemodynamic instability surrounding the events of delivery. 90 pregnant women with severe preeclampsia were enrolled. After spontaneous onset of postpartum diuresis and discontinuation of intravenous magnesium sulfate , patients were randomly assigned to receive either no therapy or 20 mg oral furosemide daily for 5 days with20 meq oral potassium supplement.This investigation was done between march 2013 and march 2014. primary outcome was assessment of mean of systolic and diastolic blood pressure in patients with severe preeclampsia on the third day after delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014031717041N1
Registration date: 2014-04-15, 1393/01/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-15, 1393/01/26
Registrant information
Name
Mona Shariati
Name of organization / entity
Qazvin University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6374
Email address
mshariati@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for research of Qazvin University of Medical Science
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of oral Furosemide in Postpartum Hypertension in Patients with Severe Preeclampsia in Kousar Hospital
Public title
Efficacy of oral Furosemide in Postpartum Hypertension in Patients with Severe Preeclampsia in Kousar Hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients delivered of a pregnancy at or greater than 20 weeks of gestation and diagnosed with severe preeclampsia. exclusion criteria: patients who had hypokalemia ( serum potassium less than 3 meq/l) on admission; patients who were already taking diuretics or potassium supplements for any reason; patients who demonstrated any hemodynamic instability surrounding the events of delivery.
Age
From 15 years old to 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Qazvin University Of Medical Sciences
Street address
Bahonar Blvd , Qazvin
City
Qazvin
Postal code
Approval date
2014-01-18, 1392/10/28
Ethics committee reference number
8281

Health conditions studied

1

Description of health condition studied
severe preeclampsia
ICD-10 code
O14.1
ICD-10 code description
Severe pre-eclampsia

Primary outcomes

1

Description
Assessment of mean of systolic and diastolic blood pressure in patients with severe preeclampsia
Timepoint
third day after delivery every 4 hours
Method of measurement
manometer

Secondary outcomes

1

Description
amount of weight loss after delivery
Timepoint
first and third day after delivery
Method of measurement
mechanical personal scale

Intervention groups

1

Description
After spontaneous onset of postpartum diuresis and discontinuation of intravenous magnesium sulfate , patients were randomly assigned to receive 20 mg oral furosemide daily for 5 days with20 meq oral potassium supplement.
Category
Prevention

2

Description
After spontaneous onset of postpartum diuresis and discontinuation of intravenous magnesium sulfate , patients in control group receive no therapy.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Mona Shariati
Street address
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for research of Qazvin University of Medical Science
Full name of responsible person
Dr Sayed Assefzadeh
Street address
Bahonar Blvd, Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for research of Qazvin University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Mona Shariati
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Kosar Hospita, Taleghani st.
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
mshariati@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Mona Shariati
Position
Resident of gynecology and obstetric
Other areas of specialty/work
Street address
Kosar Hospita, Taleghani st.
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
mshariati@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin university of medical sciences
Full name of responsible person
Mona Shariati
Position
Resident of Gynecology and Obstetric
Other areas of specialty/work
Street address
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
mshariati@qums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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