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IRCT201108054025N3 IRCT 2011-10-26 Vice Chancellor for research, Kermanshah University of Medical Sciences. Investigation of transdermal nitroglycerine effect on preterm labor. Investigation of transdermal nitroglycerine effect on preterm labor. 2011-10-23 anticipated 84 Complete https://irct.ir/trial/4208 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Preterm labour. Intervention 1: Intervention group; 42 pregnant women with diagnosis of preterm labor will be treated by10 mg nitroglycerine patch that will be applied on abdomen. 1 hour later vaginal exam will be done and uterine contractions will be assessed then another patch will be added .24 hour later two patches will be removed, vaginal exam will be done and uterine contractions will be assessed and patch site redness will be checked, if uterine contractions continues or cervical dilation progress then two another patches will be applied. These2 patches also will be removed after48 hours after randomization. If complication such as severe headache or hypo tension will be occurs at any time, patches will be removed. Intervention 2: Control group; 42 pregnant women with diagnosis of preterm labor will be treated by placebo patch that will be applied on abdomen. 1 hour later vaginal exam will be done and uterine contractions will be assessed then another patch will be added .24 hour later two patches will be removed, vaginal exam will be done and uterine contractions will be assessed and patch site redness will be checked if uterine contractions continues or cervical dilation progress then two another patches will be applied. These2 patches also will be removed after48 hours after randomization. If complication such as severe headache or hypo tension will be occurs at any time, patches will be removed.
public Parnian Kord Jamshidi
Parastar blvd., Sorkheh lyjeh, Kermanshah University of Medical Sciences, Obstetrics & Gynecology Department, Imam Reza Hospital,
Kermanshah Iran (Islamic Republic of) +98 918 842 5419 parnian_kurd@yahoo.com Kermanshah University of Medical Sciences. scientific Anisodowleh Nankali
Parastar blvd., Sorkheh lyjeh, Obstetrics& Gynecology Department, Imam Reza Hospital.
Kermanshah Iran (Islamic Republic of) +98 918 131 4921 anankali@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 15 _45 years singleton pregnant women; GA 27_ 35 weeks with painful uterine contractions; equal or more than 4 contractions per 20 min or bishop score equal or more than 3. Exclusion criteria: maternal or fetal indication for termination of pregnancy; multiple gestation; premature rupture of membrane; fetal anomaly; cervical dilatation equal or more than 5 cm; sensitivity to nitrates or nitrates contraindications; chorioamnionitis (maternal fever ,leukocytosis, fetal tachycardia); maternal heart disease; Vasa previa; Placenta previa; vaginal bleeding except bloody show. 15 years 45 years Female O60 Preterm labour Treatment - Drugs Placebo Intervention group; 42 pregnant women with diagnosis of preterm labor will be treated by10 mg nitroglycerine patch that will be applied on abdomen. 1 hour later vaginal exam will be done and uterine contractions will be assessed then another patch will be added .24 hour later two patches will be removed, vaginal exam will be done and uterine contractions will be assessed and patch site redness will be checked, if uterine contractions continues or cervical dilation progress then two another patches will be applied. These2 patches also will be removed after48 hours after randomization. If complication such as severe headache or hypo tension will be occurs at any time, patches will be removed. Control group; 42 pregnant women with diagnosis of preterm labor will be treated by placebo patch that will be applied on abdomen. 1 hour later vaginal exam will be done and uterine contractions will be assessed then another patch will be added .24 hour later two patches will be removed, vaginal exam will be done and uterine contractions will be assessed and patch site redness will be checked if uterine contractions continues or cervical dilation progress then two another patches will be applied. These2 patches also will be removed after48 hours after randomization. If complication such as severe headache or hypo tension will be occurs at any time, patches will be removed. Delivery. Timepoint: 24& 48 hour. Method of measurement: Delivery is don or delivery is not done. Mean arterial pressure. Timepoint: At randomization and 1 h, 24 h& 48 h later. Method of measurement: mmHg. Maternal heart rate. Timepoint: At randomization and 1 h, 24 h& 48 h later. Method of measurement: Beat/min. Number of doses of corticosteroid . Timepoint: At randomization and24 h after randomization. Method of measurement: Number. Fetal heart rate. Timepoint: At randomization and one hour later. Method of measurement: Beat/min. Incidence of complication (headache, vertigo, nausea, vomiting, skin redness, hypo tension). Timepoint: From randomization till 48 h later. Method of measurement: it is done or it is not done (patient complaint: headache, vertigo, nausea, vomiting or measured by investigator: skin redness, hypo tension). Change in cervical dilatation. Timepoint: At randomization and 1 h, 24 h& 48 h later. Method of measurement: cm. Vice Chancellor for research, Kermanshah University of Medical Sciences. Approved 2011-07-02 Ethics committee of Kermanshah University of Medical Sciences Parastar blv, Sorkhehlyjeh, Imam reza hospital. Kermanshah Iran (Islamic Republic of)