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Protocol summary
Gestational age, neonatal birth weight, hospitalization of the neonate in NICU ward
Neonatal birth weight, hospitalization of the neonate in NICU ward
Gestational age, neonatalNeonatal birth weight, hospitalization of the neonate in NICU ward
پیامد اولیه:
سن حاملگی، وزن تولد نوزاد، بستری شدن نوزاد در بخش مراقبتهای ویژه
وزن تولد نوزاد، بستری شدن نوزاد در بخش مراقبتهای ویژه
پیامد اولیه: سن حاملگی، وزن تولد نوزاد، بستری شدن نوزاد در بخش مراقبتهای ویژه
Ethics committees
#1
2020-08-23, 1399/06/02
2020-08-22, 1399/06/01
2020-08-2322 00:00:00
Protocol summary
Study aim
To assess the effect of nifedipine with and without sildenafil citrate on management of preterm labor in pregnant women
Design
This is a triple-blind randomized clinical trial, phase III, in which 126 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible pregnant women referring to the Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be triple-blinded so that neither patients nor the physician examining the patients, and data analyzer will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 15 to 45 years,
Pregnant women,
Gestational age of 24 to 36 weeks.
Exclusion criteria:
Proven chorioamnionitis,
Cervical dilatation more than 4 cm,
Rupture of the amniotic sac,
Chronic diseases (hypertension, renal failure, diabetes)
Tocolytic contraindication,
Contraindication of nifedipine or sildenafil,
Previous history of preterm labor
Intervention groups
Intervention group: Routine care plus nifedipine tablet (manufacture by Zahravi Pharmaceutical Co.) 20 mg every 8 hours for one day and sildenafil vaginal tablet (manufacture by Pars Darou Pharmaceutical Co.) 25 mg every 8 hours for one day.
Control group: Routine care plus nifedipine tablet (manufacture by Zahravi Pharmaceutical Co.) 20 mg every 8 hours for one day.
Main outcome variables
Neonatal birth weight, hospitalization of the neonate in NICU ward
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N382
Registration date:2021-02-08, 1399/11/20
Registration timing:prospective
Last update:2022-05-12, 1401/02/22
Update count:1
Registration date
2021-02-08, 1399/11/20
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nifedipine with and without sildenafil citrate on management of preterm labor in pregnant women: a triple-blind randomized clinical trial
Public title
Effect of nifedipine with and without sildenafil citrate on management of preterm labor in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 15 to 45 years,
Pregnant women,
Gestational age of 24 to 36 weeks
Exclusion criteria:
Proven chorioamnionitis,
Cervical dilatation more than 4 cm,
Rupture of the amniotic sac,
Chronic diseases (hypertension, renal failure, diabetes)
Tocolytic contraindication,
Contraindication of nifedipine or sildenafil,
Previous history of preterm labor
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Thus, the trial will be run as triple-blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-08-22, 1399/06/01
Ethics committee reference number
IR.UMSHA.REC.1399.484
Health conditions studied
1
Description of health condition studied
Preterm labor
ICD-10 code
O60
ICD-10 code description
Preterm labor
Primary outcomes
1
Description
Gestational age
Timepoint
At delivery
Method of measurement
By taking history
2
Description
Neonatal birth weight
Timepoint
At delivery
Method of measurement
by scale
3
Description
Hospitalization of the neonate in NICU ward
Timepoint
After delivery
Method of measurement
Based on the medical record
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care plus nifedipine tablet (manufacture by Zahravi Pharmaceutical Co.) 20 mg every 8 hours for one day and sildenafil vaginal tablet (manufacture by Pars Darou Pharmaceutical Co.) 25 mg every 8 hours for one day
Category
Treatment - Drugs
2
Description
Control group: Routine care plus nifedipine tablet (manufacture by Zahravi Pharmaceutical Co.) 20 mg every 8 hours for one day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Dr. Seyedeh Arezoo Hoseini
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
Arezoo.hoseini.md@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Arezoo Hoseini
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Arezoo.hoseini.md@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Shahla Narollahi
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
nasrollahi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available