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Trial record 37 of 143 for:    NIFEDIPINE

Transdermal Nitroglycerin and Nifedipine in Preterm Labor

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ClinicalTrials.gov Identifier: NCT02583633
Recruitment Status : Completed
First Posted : October 22, 2015
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Payam Peymani, Shiraz University of Medical Sciences

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

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Study Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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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;

  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



Primary Outcome Measures :
  1. Time of Delivery [ Time Frame: Delivery ]

Secondary Outcome Measures :
  1. APGAR scores [ Time Frame: 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).




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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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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     History of Changes
Other Study ID Numbers: ShirazSUMS
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Nifedipine
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Nitroglycerin
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents