Transdermal Nitroglycerin and Nifedipine in Preterm Labor

NCT02583633 | Completed Phase 4 DMC

• 1 other identifier: ShirazSUMS
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time of Delivery

  Delivery

Secondary Outcomes (1)

• APGAR scores

  Delivery

Study Arms (2)

Group one have received Transdermal nitroglycerin

ACTIVE COMPARATOR

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.

Drug: Transdermal nitroglycerin

Group two have received nifedipine

ACTIVE COMPARATOR

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.

Drug: nifedipine

Interventions

Transdermal nitroglycerin DRUG

Group one have received Transdermal nitroglycerin

nifedipine DRUG

Group two have received nifedipine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%).

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Related Publications (1)

• 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.

  PMID: 35947046 DERIVED

MeSH Terms

Interventions

Nifedipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Of Biostatistics Department, Health policy Research Center,Shiraz university of Medical Sciences

Study Record Dates

• First Submitted: October 18, 2015
• First Posted: October 22, 2015
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 22, 2015

Record last verified: 2015-10