Transdermal Nitroglycerin and Nifedipine in Preterm Labor

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02583633

Collaborator

(none)

112

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Managing Preterm Labor	Drug: Transdermal nitroglycerin Drug: nifedipine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Transdermal Nitroglycerin and Nifedipine for Managing Preterm Labor: a Randomized Clinical Trial

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Transdermal nitroglycerin
Active Comparator: 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; One softgel every 20 min (4 doses) Two softgel every 6 hr (4 doses) One softgel every 6 hr (4 doses) 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

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Transdermal nitroglycerin

Active Comparator: 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; One softgel every 20 min (4 doses) Two softgel every 6 hr (4 doses) One softgel every 6 hr (4 doses) 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

Outcome Measures

Primary Outcome Measures

Time of Delivery [Delivery]

Secondary Outcome Measures

APGAR scores [Delivery]
The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration). The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT02583633

Other Study ID Numbers:

ShirazSUMS

First Posted:

Oct 22, 2015

Last Update Posted:

Oct 22, 2015

Last Verified:

Oct 1, 2015

Additional relevant MeSH terms:

Premature Birth

Obstetric Labor, Premature

Nifedipine

Nitroglycerin

Study Results

No Results Posted as of Oct 22, 2015