Investigation of transdermal nitroglycerine effect on preterm labor.
Phase 2
- Conditions
- Preterm labour.Preterm labour
- Registration Number
- IRCT201108054025N3
- Lead Sponsor
- Vice Chancellor for research, Kermanshah University of Medical Sciences.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 84
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delivery. Timepoint: 24& 48 hour. Method of measurement: Delivery is don or delivery is not done.
- Secondary Outcome Measures
Name Time Method 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.