A Comparison of nitroglycerine skin patch and sublingual tablets of isosorbide di-nitrate for prevention of preterm labor

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2017071535090N1
• Date of registration: 2017-08-19
• Prospective Registration: Yes
• Primary sponsor: Lorestsn University Of Medical Sciences. Lorestan, Iran
• Public title: A Comparison of nitroglycerine skin patch and sublingual tablets of isosorbide di-nitrate for prevention of preterm labor
• Scientific title: A comparison of TNG skin patch and Isosorbide di-nitrate for prevention of preterm labor.
• Date of first enrolment: 2017-10-04
• Target sample size: 110
• Recruitment status: Recruiting
• URL: http://en.irct.ir/trial/26620
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Masoomeh Ghafarzade
• Affiliation: Lorestsn University Of Medical Sciences. Lorestan, Iran

• Name: Mehrnaz Mehrkhu
• Affiliation: Lorestsn University Of Medical Sciences. Lorestan, Iran

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: Healthy pregnant women aged 18-35; live fetus with gestational age of 34-36 weeks; having at least 8 regular uterine contractions in an hour

Exclusion criteria: rupture of membranes (ROM) ; onset of active labor phase (4 cm dilatation and more) ; vaginal bleeding or symptoms of placenta abruption, Chorioamnionitis, pyelonephritis, Pulmonary heart disease, Diabetes and pregnancy hypertension ; receiving Tocolytic in the past 24 hours
Exclusion criteria:

Age minimum: 18 years
Age maximum: 35 years
Gender: Female

Health Condition(s) or Problem(s) studied

preterm labor.
Preterm spontaneous labour with preterm delivery

Preterm spontaneous labour with preterm delivery

Intervention(s)

Intervention 1: Control group: In the group of TNG skin patch, first, ten mg TNG skin patch will be attached to the lateral arm and the patient will be evaluated about the process of uterine contractions, for an hour. If contractions persist, (eight contractions per hour with a minimum contraction time of 30 seconds) , another skin patch will be used one hour later. For each patient, up to two ten mg TNG skin patch will be used. The location of the tags is the same for all patients. Intervention 2: Intervention group: In the Isosorbide di-nitrate group, we provide the patient Isosorbide dinitrate five mg sublingual tablets, every half an hour (Because the half-life is 45 minutes) and we will continue it until the contractions ends. However it should be noted that the maximum dose is up to eight doses (the maximum dose in adults is 120 mg per day) . In the event of discontinuation of contractions, ten mg isosorbide di-nitrate tablets will be given to them one hour later and it will be continued every six hours to 48 hours.

Intervention group: In the Isosorbide di-nitrate group, we provide the patient Isosorbide dinitrate five mg sublingual tablets, every half an hour (Because the half-life is 45 minutes) and we will continue it until the contractions ends. However it should be noted that the maximum dose is up to eight doses (the maximum dose in adults is 120 mg per day) . In the event of discontinuation of contractions, ten mg isosorbide di-nitrate tablets will be given to them one hour later and it will be continued every six hours to 48 hours.

Control group: In the group of TNG skin patch, first, ten mg TNG skin patch will be attached to the lateral arm and the patient will be evaluated about the process of uterine contractions, for an hour. If contractions persist, (eight contractions per hour with a minimum contraction time of 30 seconds) , another skin patch will be used one hour later. For each patient, up to two ten mg TNG skin patch will be used. The location of the tags is the same for all patients.

Prevention

Primary Outcome(s)

Preterm labor. Timepoint: Before intervention and 1 hour after intervention. Method of measurement: By physical examination.

Secondary Outcome(s)

Cervical length. Timepoint: Before intervention and 1 hour after intervention. Method of measurement: By physical examination.

Blood pressure. Timepoint: Before the intervention, 15 minutes after the intervention, 30 minutes after the intervention, 45 minutes after the intervention, 1 hour after the intervention, and then every 4 hours. Method of measurement: By manometer.

Source(s) of Monetary Support

Lorestsn University Of Medical Sciences. Lorestan, Iran

Ethics review

Status: Approved
Approval date:
Contact:

Lorestsn University Of Medical Sciences. Lorestan, Iran