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Transdermal Nitroglycerin and Nifedipine in Preterm Labor

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02583633
Enrollment
112
Registered
2015-10-22
Start date
2013-10-31
Completion date
2014-10-31
Last updated
2015-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Managing Preterm Labor

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.

Interventions

DRUGnifedipine

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frame
Time of DeliveryDelivery

Secondary

MeasureTime frameDescription
APGAR scoresDeliveryThe 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026