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CompletedNCT02583633Updated Oct 22, 2015

Transdermal Nitroglycerin and Nifedipine in Preterm Labor

A Phase 4 interventional study of Transdermal nitroglycerin and nifedipine in Managing Preterm Labor, sponsored by Shiraz University of Medical Sciences. Completed. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-22.

Sponsored by Shiraz University of Medical Sciences · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

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Conditions studied

  • Managing Preterm Labor
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In context

Lead sponsor

Shiraz University of Medical Sciences is the lead sponsor of 130 studies on the registry; 6 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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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Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
112 participants (actual)

Study arms

  • 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

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What researchers measure

Primary outcomes

  1. Time of Delivery

    Time frame: Delivery

Secondary outcomes

  1. APGAR scores

    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).

    Time frame: Delivery

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 35947046 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2013, a primary completion of Oct 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2015
First posted
Oct 22, 2015
Start
Oct 2013
Primary completionActual
Oct 2014
CompletionActual
Oct 2014
Last update
Oct 22, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02583633
Lead sponsor
Shiraz University of Medical Sciences
Responsible party
Payam Peymani (Head Of Biostatistics Department, Health policy Research Center,Shiraz university of Medical Sciences, Shiraz University of Medical Sciences) — Principal investigator
First posted
Oct 22, 2015
Start date
Oct 2013
Primary completion
Oct 2014
Completion
Oct 2014
Last update
Oct 22, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Nitroglycerin · Nifedipine

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