Transdermal Nitroglycerin and Nifedipine in Preterm Labor

NCT ID: NCT02583633

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-10-31

Brief Summary

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.

Conditions

Managing Preterm Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group one have received Transdermal nitroglycerin

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.

Group Type: ACTIVE_COMPARATOR

Transdermal nitroglycerin

Intervention Type: DRUG

Group two have received nifedipine

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.

Group Type: ACTIVE_COMPARATOR

nifedipine

Intervention Type: DRUG

Interventions

Transdermal nitroglycerin

Intervention Type: DRUG

nifedipine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Payam Peymani

Head Of Biostatistics Department, Health policy Research Center,Shiraz university of Medical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.

Reference Type: DERIVED

PMID: 35947046 (View on PubMed)

Other Identifiers

ShirazSUMS

Identifier Type: -

Identifier Source: org_study_id