Managing Preterm LaborPhase 4NCT02583633
Transdermal Nitroglycerin and Nifedipine in Preterm Labor
A Phase 4 study testing Transdermal nitroglycerin and nifedipine in people with Managing Preterm Labor, run by Shiraz University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Managing Preterm Labor
- What is being tested?
- Transdermal nitroglycerin and nifedipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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%).
Who cannot join
- 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
About this study
Official title: Transdermal Nitroglycerin and Nifedipine for Managing Preterm Labor: a Randomized Clinical Trial
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.
- Conditions
- Managing Preterm Labor
- Being tested
- Transdermal nitroglycerin, nifedipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal nitroglycerinDrug
nifedipineDrug
| Study group | Role | What they receive |
|---|---|---|
| Group one have received Transdermal nitroglycerin | Active comparator | 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. Receives: Drug: Transdermal nitroglycerin |
| Group two have received nifedipine | Active comparator | 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. Receives: Drug: nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Delivery
Measured: 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).
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Managing Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Payam Peymani, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583633
- Sponsor's protocol ID
- ShirazSUMS
- Status last verified
- Oct 2015
- First submitted
- 18 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Nitroglycerin and Nifedipine for Managing Preterm Labor: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02583633
- Acronym / sponsor ID
- ShirazSUMS
- Conditions
- Managing Preterm Labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group one have received Transdermal nitroglycerin | Active comparator | Drug: Transdermal nitroglycerintransdermal 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. |
| Group two have received nifedipine | Active comparator | Drug: nifedipineFor 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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%).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal nitroglycerin | Drug | Group one have received Transdermal nitroglycerin |
| nifedipine | Drug | Group two have received nifedipine |
Primary outcome
Time of Delivery
Time frame: Delivery
1 secondary outcome
APGAR scores
Time frame: Delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
- Derived from this study: PubMed 35947046Wilson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transdermal nitroglycerin and nifedipine in people with Managing Preterm Labor, run by Shiraz University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of Delivery (time frame: Delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02583633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.