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Investigation of transdermal nitroglycerine effect on preterm labor.

Investigation of transdermal nitroglycerine effect on preterm labor.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201108054025N3
Enrollment
84
Registered
2011-10-26
Start date
2011-10-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm labour. Preterm labour

Interventions

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
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 the
Treatment - Drugs
Placebo
Intervention group
Control group

Sponsors

Vice Chancellor for research, Kermanshah University of Medical Sciences.
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Delivery. Timepoint: 24& 48 hour. Method of measurement: Delivery is don or delivery is not done.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParnian Kord Jamshidi

Kermanshah University of Medical Sciences.

parnian_kurd@yahoo.com+98 918 842 5419

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026