The effect of Low-dose aspirin on cervical length as an indicator of preterm delivery in nulliparous pregnant women that has been referred to gynecology clinic in Semnan
Objective: the effect of low-dose aspirin on cervical length as an indicator of preterm delivery in nulliparous pregnant women.
Design and methods: random (binary random blocks); one center; double-blind; placebo; intervention and control groups.
Inclusion criteria: Age between 18 to 40 years; nulliparous; less than 2 miscarriage.
Exclusion criteria: history of abortion; contraindication of aspirin usage; smoking and drugs usage; multiple pregnancy; visible fetal anomalies; uterine anomalies.
Interventions and main outcome variables: To apply rigorous random assignment, in the first drugs by anyone other than researcher was placed in special packages and packages are labeled with A and B tag.
Interventions group: 80 mg of aspirin daily (bedtime) in combination with folic acid + iron tablets from the second trimmest will be prescribed to patients and up to 32 weeks of pregnancy to taking medicine.
Controls group: Daily folic acid with placebo (Consisting of sugar and starch that the shape, size and color is quite similar to aspirin) + iron tablets will be prescribed to patients.
To apply rigorous random assignment, in the first drugs by anyone other than researcher was placed in special packages and packages are labeled with A and B tag.
These people will be examined to using the history and physical examination by researchers plan periodically.
The cervical length and also blood hemoglobin, once a time at 13 weeks and once again at 30 weeks of pregnancy will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052825732N15
Registration date:2017-06-01, 1396/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-01, 1396/03/11
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-10-21, 1395/07/30
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Low-dose aspirin on cervical length as an indicator of preterm delivery in nulliparous pregnant women that has been referred to gynecology clinic in Semnan
Public title
The effect of Low-dose aspirin on cervical length as an indicator of preterm delivery in nulliparous pregnant women that has been referred to gynecology clinic in Semnan
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 40 years; nulliparous; the singleton pregnancy is between 12 to 13 weeks of pregnancy that is confirmed to medical ultrasound; less than 2 miscarriage in the first 3 months of pregnancy.
Exclusion criteria: history of loss pregnancy in second trimester; contraindication of aspirin usage; smoking and drugs usage; multiple pregnancy; visible fetal anomalies by medical ultrasound; hemoglobin level less than 7 milligram per deciliter; previous risk of systemic diseases; individuals with short cervical length less than 25 millimeter; uterine anomalies.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
semnan
Postal code
3514799442
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.SEMUMS.REC.1396.9
Health conditions studied
1
Description of health condition studied
Preterm labour
ICD-10 code
O60.0
ICD-10 code description
Preterm labour without delivery
Primary outcomes
1
Description
Measurement of cervical length
Timepoint
Week 13 and week 30 of pregnancy
Method of measurement
Transvaginal ultrasound
2
Description
Blood hemoglobin
Timepoint
Week 13 and week 30 of pregnancy
Method of measurement
Complete Blood Counter
Secondary outcomes
empty
Intervention groups
1
Description
Interventions group: 80 mg of aspirin daily (bedtime) in combination with folic acid + iron tablets from the second trimmest will be prescribed to patients
To apply rigorous random assignment, in the first drugs by anyone other than researcher was placed in special packages and packages are labeled with A and B tag.
Participants will start to taking experimental drug and up to 32 weeks of pregnancy (based on medical ultrasound) to continue taking medicine. These people will be examined to using the history and physical examination by researchers plan periodically. The cervical length (using the transvaginal ultrasound method) and also blood hemoglobin (using the complete blood counter in laboratory of Amiralmomenin hospital in Semnan) once a time at 13 weeks and once again at 30 weeks of pregnancy (based on medical ultrasound) will be measured. During periodical examination of pregnancy, the outcome measures are extracted from patients medical records and be recorded in the relevant forms.
Category
Treatment - Drugs
2
Description
Controls group: Daily folic acid with placebo (Consisting of sugar and starch that the shape, size and color is quite similar to aspirin) + iron tablets will be prescribed to patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology clinic, Amir almoemenin Hospital
Full name of responsible person
Mozhgan Rahmanian
Street address
Amir almoemenin Hospital, Blvd Mostafa Khomeini, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Asgari
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
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 and Technology, Semnan 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
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mozhgan Rahmanian
Position
Gynecologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
are20935@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mozhgan Rahmanian
Position
Gynecologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
are20935@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mozhgan Rahmanian
Position
Gynecologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)