search
Back to results

Transdermal Nitroglycerin and Nifedipine in Preterm Labor

Primary Purpose

Managing Preterm Labor

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Transdermal nitroglycerin
nifedipine
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Managing Preterm Labor

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group one have received Transdermal nitroglycerin

    Group two have received nifedipine

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Time of Delivery

    Secondary Outcome Measures

    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).

    Full Information

    First Posted
    October 18, 2015
    Last Updated
    October 20, 2015
    Sponsor
    Shiraz University of Medical Sciences
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02583633
    Brief Title
    Transdermal Nitroglycerin and Nifedipine in Preterm Labor
    Official Title
    Transdermal Nitroglycerin and Nifedipine for Managing Preterm Labor: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shiraz University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Managing Preterm Labor

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    112 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group one have received Transdermal nitroglycerin
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group two have received nifedipine
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Transdermal nitroglycerin
    Intervention Type
    Drug
    Intervention Name(s)
    nifedipine
    Primary Outcome Measure Information:
    Title
    Time of Delivery
    Time Frame
    Delivery
    Secondary Outcome Measure Information:
    Title
    APGAR scores
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35947046
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Transdermal Nitroglycerin and Nifedipine in Preterm Labor

    We'll reach out to this number within 24 hrs