Protocol summary
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Study aim
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To assess the effect of nifedipine with and without sildenafil citrate on management of preterm labor in pregnant women
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Neonatal birth weight, hospitalization of the neonate in NICU ward
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2021-02-08, 1399/11/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-02-19, 1399/12/01
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Expected recruitment end date
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2021-05-21, 1400/02/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of nifedipine with and without sildenafil citrate on management of preterm labor in pregnant women: a triple-blind randomized clinical trial
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Public title
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Effect of nifedipine with and without sildenafil citrate on management of preterm labor in pregnant women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 15 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
126
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-08-22, 1399/06/01
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Ethics committee reference number
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IR.UMSHA.REC.1399.484
Health conditions studied
1
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Description of health condition studied
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Preterm labor
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ICD-10 code
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O60
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ICD-10 code description
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Preterm labor
Primary outcomes
1
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Description
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Gestational age
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Timepoint
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At delivery
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Method of measurement
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By taking history
2
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Description
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Neonatal birth weight
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Timepoint
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At delivery
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Method of measurement
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by scale
3
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Description
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Hospitalization of the neonate in NICU ward
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Timepoint
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After delivery
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Method of measurement
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Based on the medical record
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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Control group: Routine care plus nifedipine tablet (manufacture by Zahravi Pharmaceutical Co.) 20 mg every 8 hours for one day
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available