Aspirin effect in the prevention of preterm labor in patient with previous spontaneous preterm birth
Design
randomized clinical trial with control group,Parallel groups, 190 patient in each group
Settings and conduct
This study will be performed with the participation of pregnant mothers over 18 years of age with singleton pregnancy between 8 to 16 weeks gestation and history of spontaneous preterm birth referred to Mahdieh and Shohada hospitals. Pregnant mothers with inclusion criteria will be randomly divided into intervention and non-intervention groups. All participants' information including demographic information, pregnancy history and maternal illness will be recorded at baseline. After the participants will be assigned to the intervention and non-intervention groups, the intervention group will be given 80 mg daily aspirin tablets produced by Hakim Pharmaceutical Company and the non-intervention group will not be given aspirin. Routine prenatal visits will be made for both groups. Information about pregnancy and childbirth care, including gestational age at delivery, baby weight and Apgar, will be recorded. The data will be collected using a data log checklist.
Participants/Inclusion and exclusion criteria
Singleton pregnancy
Gestational age 8-16 weeks
Maternal age upper than 18 years old
Previous spontaneous preterm birth
Intervention groups
The intervention group will be given 80 mg daily aspirin tablets produced by Hakim Pharmaceutical Company and the control group will not be given aspirin. Other measures indicated for the prevention of preterm labor in the patient will be performed (from 16 weeks of proletone weekly to 36 weeks, and cerclage if CL> 25). Routine prenatal visits will be made for both groups.
Main outcome variables
Incidence of preterm labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191031045289N1
Registration date:2020-02-26, 1398/12/07
Registration timing:registered_while_recruiting
Last update:2020-02-26, 1398/12/07
Update count:0
Registration date
2020-02-26, 1398/12/07
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
2019-12-22, 1398/10/01
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aspirin Effect in the Prevention of Preterm Labor in Patient with Previous Spontaneous Preterm Birth
Public title
Aspirin Effect in the Prevention of Preterm Labor in Patient with Previous Spontaneous Preterm Birth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Singleton pregnancy
Gestational age 8-16 weeks
Maternal age upper than 18 years old
Previous spontaneous preterm birth
Exclusion criteria:
History of preterm labor due to maternal cause
Have other indications of aspirin use
Thrombocytopenia
Embryonic malformations in this pregnancy or previous preterm pregnancy
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
380
Randomization (investigator's opinion)
Randomized
Randomization description
Pregnant mothers with inclusion criteria will be selected as available sample and then will be randomly divided into intervention and non-intervention groups using random number table.
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. 115, Teymourifar Ave., Emamat St.
City
Tehran
Province
Tehran
Postal code
1743674181
Approval date
2019-12-08, 1398/09/17
Ethics committee reference number
IR.SBMU.MSP.REC.1398.528
Health conditions studied
1
Description of health condition studied
Preterm Birth
ICD-10 code
O60
ICD-10 code description
Preterm labor
Primary outcomes
1
Description
Preterm Labor
Timepoint
Pregnancy termination time
Method of measurement
Gestational age at delivery time
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the intervention group will be given 80 mg daily aspirin tablets produced by Hakim Pharmaceutical Company. Routine prenatal visits will be made for this groups.Other measures indicated for the prevention of preterm labor in the patient will be performed (from 16 weeks of proletone weekly to 36 weeks, and cerclage if CL> 25).
Category
Treatment - Drugs
2
Description
Control group: the control group will not be given aspirin. Routine prenatal visits will be made for this groups. Other measures indicated for the prevention of preterm labor in the patient will be performed (from 16 weeks of proletone weekly to 36 weeks, and cerclage if CL> 25).