Transdermal Nitroglycerin and Nifedipine in Preterm Labor

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Managing Preterm Labor

Treatments: Drug: Transdermal nitroglycerin; Drug: nifedipine

Study type: Interventional

Funder types: Other

Identifiers

NCT02583633

ShirazSUMS

Details and patient eligibility

About

One of the important complications of pregnancy is preterm labor (PTL) and delivery. There are different tocolytic agents to enhance the time of delivery. The aim of this study was to compare the effect of transdermal nitroglycerin (glyceryl trinitrate, GTN) and oral nifedipine for managing preterm labor. This was a randomized clinical trial in women admitted with diagnosis of PTL. Group one have received transdermal GTN whereas group two have received oral nifedipine, vital signs, FHR, contractions, dilation and effacement as well as gestation age at the time of delivery have been monitored and evaluated in both groups of patient. Our main goal has been delay of delivery to have the most beneficial effect of primary corticosteroid administration for fetus.

Enrollment: 112 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• GA between 24 to 34 weeks
• early-onset signs of delivery (≥4 uterine contractions during 20 minutes, ≥1 centimeters (cm) of dilation and effacement over 80%).

Exclusion criteria

• maternal or fetal life-threatening conditions which require emergency termination
• multiple pregnancy
• premature rupture of membrane
• fatal anomaly or intra-uterine fetal death
• cervical dilation ≥4 cm
• any tocolytic treatment in previous days and positive allergy to GTN

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

112 participants in 2 patient groups

Group one have received Transdermal nitroglycerin

Active Comparator group

Description:

transdermal GTN (Schwarz Pharma AG, Monheim, FRG) were prescribed and placed on the patient forearm. Each patch contained 37.4 mg of glyceryl trinitrate which was released in blood stream (10mg/24hour). After one hour of the first patch application, the uterine contractions were evaluated.

Treatment:

Drug: Transdermal nitroglycerin

Group two have received nifedipine

Active Comparator group

Description:

For the nifedipine group, nifedipine 5mg softgel (Daana Pharma Co., Tabriz, Iran) was prescribed. In this group, the order of medicine prescription was as below; 1. One softgel every 20 min (4 doses) 2. Two softgel every 6 hr (4 doses) 3. One softgel every 6 hr (4 doses) 4. One softgel every 8 hr (3 doses) Likewise, the uterine contractions were checked every one hour and if the contraction didn't subside or there was any change in dilation and effacement, the treatment were stopped and another tocolytic were applied.

Treatment:

Drug: nifedipine