Protocol summary

Summary
Objective: to compare the effect of aspirin on blood pressure in two different diurnal times (morning and night) in women at preeclampsia risk. Method: 64 pregnant women randomly assigned to 4 groups. Testing group 1 (100 mg /day aspirin after awakening), testing group2 (100mg/day aspirin at bed time), control group1( placebo after awakening) and control group2 ( placebo at bed time). Inclusion criteria: women at higher risk for gestational hypertension and preeclampsia such as women with family history of gestational hypertension and preeclampsia, history of spontaneous abortion, obesity, adolescent or middle age nulliporous pregnancy (less than 18 or more than 35 years). Exclusion criteria: any needs to steroidal or non steroidal or hypertensive drugs, multiple pregnancy, any cardiovascular disease, chronic gastroenteritis and adrenal disease, asthma, hemorrhage disease, diabetes or any other endocrine disease such as hyperthyroidism, hematological disease and intolerance to devise (Ambulatory blood pressure monitoring), abortion, preeclampsia or eclampsia happening in pregnancy, forgetting > 6 tablet in month. The study was started at 12 to16 weeks of gestation and continued until 32 weeks of gestation. Blood pressure was automatically monitored for 24 consecutive hours every 4 weeks from the day of recruitment until delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138803211548N5
Registration date: 2010-02-20, 1388/12/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-02-20, 1388/12/01
Registrant information
Name
Khadijeh Abdali
Name of organization / entity
Fatemeh college of nursing and midwifery, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4255
Email address
abdalikh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research of Shiraz University of Medical Sciences
Expected recruitment start date
2008-04-12, 1387/01/24
Expected recruitment end date
2008-12-12, 1387/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of taking aspirin in two different diurnal times (morning and night) on mean of 24 hours blood pressure in women who are at preeclampsia risk
Public title
To compare The effect of taking aspirin and placebo in two different diurnal times (morning and night) on mean of 24 hours blood pressure in women who are at preeclampsia risk
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women with personal and family history of gestational hypertension and preeclampsia, history of spontaneous abortion, obesity, adolescent or middle age nulliporous pregnancy (less than 18 or more than 35 years). Exclusion criteria: using steroidal , non steroidal or antihypertensive drugs, multiple pregnancy, cardiovascular disease, chronic gastroenteritis and adrenal disease, asthma, hemorrhage disease, diabetes or any other endocrine disease ,hyperthyroidism, hematological disease ,intolerance to devise ,Ambulatory blood pressure monitoring.
Age
From 17 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of Shiraz University of medical sciences
Street address
Namazi squer
City
Shiraz
Postal code
Approval date
2008-09-10, 1387/06/20
Ethics committee reference number
87-4227

Health conditions studied

1

Description of health condition studied
Preeclampsia
ICD-10 code
010
ICD-10 code description
Pre-existing hypertension complicating pregnancy, childbirth and the puerperium

Primary outcomes

1

Description
24 hours mean of blood pressure
Timepoint
7 times, every month from the day of recruitment
Method of measurement
24 hour Blood pressure monitoring automatic device

Secondary outcomes

1

Description
preeclampsia prevention and decrease fetal and maternal complications
Timepoint
during and at the end of the pregnancy
Method of measurement
clinically and sonography approved by specialist

Intervention groups

1

Description
testing group 1: aspirin (100mg) at awakening, 1 pill per day
Category
Prevention

2

Description
testing group 2: aspirin (100mg) at bed time, 1 pill per day
Category
Prevention

3

Description
control group 1: placebo at awakening, 1 pill per day
Category
Prevention

4

Description
control group 2: placebo at bed time, 1 pill per day
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez clinic
Full name of responsible person
Dr. Amoee
Street address
Hafez hospital, Abivardy
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy for Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Dabaghmanesh
Street address
Shiraz Univercity of medical sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
87-4227
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research of Shiraz University of Medical Sciences
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Full name of responsible person
Dr. Amoee
Position
Obstetric and gynecology physician
Other areas of specialty/work
Street address
Hafez hospital, Abivardi
City
Shiraz
Postal code
Phone
+98 71 1627 1531
Fax
Email
abdalikh@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Khadijeh Abdali
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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