Determining the effect of adding LASIX to antihypertensive therapy (nifedipine) on the control of postpartum hypertension in women with preeclampsia
Design
randomized clinical trial with control group,Parallel groups, Not Blind, 58 patient in each group
Settings and conduct
This study will be conducted as a clinical trial with the participation of 116 women with postpartum preeclampsia who have high blood pressure and are referred to Mahdieh Hospital. Patients with inclusion criteria were selected as an available sample and then randomly divided into two groups. All women will be treated with nifedipine 10 mg every 8 hours. The static dose of nifedipine 10 mg will be increased each time the blood pressure is greater than 160/110. In the intervention group, in addition to nifedipine, furosemide tablets of 20 mg once daily from 24 hours after delivery until 3 days later will be given. Women in the control group will only be treated with nifedipine.
Participants/Inclusion and exclusion criteria
- Inclusion criteria:
• Systolic blood pressure ≥ 150mm Hg
• Diastolic blood pressure ≥ 100 mm Hg
• Urine rate> 50 ml / h
• Termination of magnesium sulfate treatment
- Exclusion criteria:
• History of chronic hypertension
• Use of diuretics
• Previous underlying renal disorders
• Having diabetes
• Hemodynamic instability
• Contraindications to the use of Lasix
Intervention groups
All patients will be treated with nifedipine 10 mg every 8 hours. The static dose of nifedipine 10 mg will be increased each time the blood pressure is greater than 160/110. In the intervention group, in addition to nifedipine, furosemide tablets of 20 mg once daily from 24 hours after delivery until 3 days later will be given. Women in the control group will only be treated with nifedipine.
Main outcome variables
Faster control of blood pressure in the postpartum period of patients with preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191031045289N2
Registration date:2020-08-06, 1399/05/16
Registration timing:prospective
Last update:2020-08-06, 1399/05/16
Update count:0
Registration date
2020-08-06, 1399/05/16
Registrant information
Name
Zahra Dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7748 0345
Email address
n.ghaemi.983@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding lasix to antihypertensive treatment in controlling postpartum hypertension in women with preeclampsia
Public title
The effect of adding lasix to antihypertensive treatment in controlling postpartum hypertension in women with preeclampsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Systolic blood pressure above 150 mm Hg
Diastolic blood pressure above 100 mm Hg
Urine rate more than 50 cc per hour
Termination of treatment with magnesium sulfate
Exclusion criteria:
History of chronic hypertension
Blood pressure less than 150/100 mm Hg
Use of diuretics
Previous underlying renal disorders
Having diabetes
Hemodynamic instability
Contraindications to the use of Lasix
Hematocrit more than 37
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with inclusion criteria will be selected as available sample and then will be randomly divided into two groups of intervention and non-intervention.
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 of Shahid Beheshti University of Medical Sciences
Street address
No 30, East 22 Ave., South allameh St.
City
Tehran
Province
Tehran
Postal code
1997843341
Approval date
2020-05-26, 1399/03/06
Ethics committee reference number
IR.SBMU.MSP.REC.1399.067
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O15.0
ICD-10 code description
Eclampsia in pregnancy
Primary outcomes
1
Description
Postpartum blood pressure control
Timepoint
From 24 hours to 5 days after delivery
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will be treated with nifedipine 10 mg every 8 hours. The static dose of nifedipine 10 mg will be increased each time the blood pressure is greater than 160/110. In this group, in addition to nifedipine, furosemide tablets of 20 mg once daily from 24 hours after delivery to 3 days later will be given. If additional medication is needed to control blood pressure, the patient will not be excluded from the study, but this will be recorded in the patient information.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will be treated with nifedipine 10 mg every 8 hours. The static dose of nifedipine 10 mg will be increased each time the blood pressure is greater than 110/160. In this group, patients will only be treated with nifedipine. If additional medication is needed to control blood pressure, the patient will not be excluded from the study, but this will be recorded in the patient information.