Preterm LaborBOG/TH/PTLNCT04644354
The Efficacy of Nifedipine in the Management of Preterm Labor
An observational study of Preterm Labor and Preterm Birth, run by Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic.
Trial summary
Preterm labor is one of the problems of obstetrics, and is one of the leading cause of neonatal morbidity and mortality. The incidence of preterm birth is around 7 to 9 %. The preterm baby is prone to respiratory, renal, neurologic and gastrointestinal problems. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Labor, Preterm Birth, Preterm Labor Without Delivery
- What is being tested?
- Nifedipine 10 mg
- Type of treatment
- Pill or oral medicine
- How many people
- 444 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2020to 30 Dec 2020
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Only pregnant women (23-37 weeks) with preterm labor
Who may be able to join
- ingleton pregnant women with spontaneous preterm labor at their 23-37 weeks.
Who cannot join
- Normal pregnant women
- Pregnent women before 23 weeks of gestation
- Pregant women between 23 and 37 weeks of gestation, but with preterm early membrane rupture, chorioamnionitis, preterm labor without cervical change, multiple pregnancy, hypertension, intrauterine growth retardation, fetal anomaly, oligoanhidramniosis, placenta previa, decolman placentaand intrauterine fetal death
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Tocolytic Efficacy of Nifedipine in the Management of Threatened and Advanced Preterm Labor: A Study on 444 Singleton Pregnant Women With Intact Membranes
Preterm labor is one of the problems of obstetrics, and is one of the leading cause of neonatal morbidity and mortality. The incidence of preterm birth is around 7 to 9 %. The preterm baby is prone to respiratory, renal, neurologic and gastrointestinal problems. The correct diagnosis should be followed by the early administration of the most effective tocolytic agent with least side effects for both mother and fetus. Nifedipine, a calcium channel blocker, has gained a world-wide popularity recently since it has the least side-effects on both mother and fetus. In the present study, we aimed to evaluate the success rate of tocolytic agent 'nifedipine' on the spontaneous preterm labor of singeton pregnant women with intact amnionic membrane.
Read the detailed description
Preterm birth is the main reason of perinatal morbidity and mortality. The main management method of this important problem is to prolong the pregnancy period and to use corticosteroids to prevent fetal pulmonary distress. The most widely studied tocolytic agents, ritodrin, salbutamol and terbutaline are all betamimetics, and they are shown to prolong birth labor till 7 days and do not have any effct on the fetal mortality. However, their maternal side-effects are inevitable and can be mortal. They cause tachycardia, hypotension and some biochemical disturbances. Furthermore, maternal death is possible due to pulmonary edema. These adrenergic agonists are the first line tocolytics, but calcium canal blockers are becoming more popular since they have less side effects and comparable efficacy.
Calcium canal blockers are nonspecific smooth muscle relaxants used in adult hypertension treatment. Their tocolytic effect depends on their inhibition of calcium ions into the myometrial cells. In vitro studies have shown that they have strong relaxant effects on human myometrium. In the present study, our aim is to investigate the effects of nifedipine in our clinic in a period between 2002 and 2005, when it was first used in our clinic as the sıngle tocolytic agent. Its success in preventing preterm labor and its complications in our earlier practice will be noted and this retrospective study will guide us in its current usage, dosages and side-effects.
- Conditions
- Preterm Labor, Preterm Birth, Preterm Labor Without Delivery, Preterm Labor With Preterm Delivery in Third Trimester, Calcium-Channel Blockers Toxicity, Side Effect of Drug
- Being tested
- Nifedipine 10 mg
- Keywords
- Nifedipine, Tocolytics
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine 10 mgDrug
For both groups, when preterm labor is diagnosed, 10 mg capsule will be given sublinguially and if it is not effective in 1 hour, the same dose will be repeated again, and the same regimen will be repeated every day till preterm labor ends or proceed to a preterm birth.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Advanced Preterm Labor (aPL) | Singleton pregnant women with spontaneous preterm labor at their 23-36 weeks: regular contractions 4 or more in 20 minutes and cervical dilatation at 2 cm and above Receives: Drug: Nifedipine 10 mg | |
| Group B - Threatened Preterm Labor (tPL) | Singleton pregnant women with spontaneous preterm labor at their 23-36 weeks: regular contractions less then 4 in 20 minutes and cervical dilatation less then 2 cm Receives: Drug: Nifedipine 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay Delivery for 1 day
After start of tocolytic nifedipine, the delay recorded till delivery is only 24 hours
Measured: 1 day
Delay Delivery for 2 days
After start of tocolytic nifedipine, the delay recorded till delivery is 48 hours
Measured: 2 days
Delay Delivery for 3 days
After start of tocolytic nifedipine, the delay recorded till delivery is 72 hours
Measured: 3 days
Delay Delivery for 7 days
After start of tocolytic nifedipine, the delay recorded till delivery is 168 hours
Measured: 7 days
Birth before 34 weeks
After start of tocolytic nifedipine, the preterm birth occurs before 34 weeks
Measured: till 34 weeks of gestation
Birth before 37 weeks
After start of tocolytic nifedipine, the preterm birth occurs before 37 weeks
Measured: till 37 weeks of gestation
Birth after 37weeks
After start of tocolytic nifedipine, the preterm birth occurs after 37 weeks (Normal birth)
Measured: after 37 weeks of gestation-normal birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start15 Dec 2020 (estimated)
- Primary completion20 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic, Umraniye Education and Research Hospital
- Investigators
- Aysun Firat, M.D., Specialist of Obstetrics&Gynecology, Dir, Principal investigator, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644354
- Sponsor's protocol ID
- BakirkoyDogumeviTez/2005
- Acronym
- BOG/TH/PTL
- Status last verified
- Nov 2020
- First submitted
- 19 Nov 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available at Excel file and be shared by email upon any request.
Publications
Flenady V, Wojcieszek AM, Papatsonis DN, Stock OM, Murray L, Jardine LA, Carbonne B. Calcium channel blockers for inhibiting preterm labour and birth. Cochrane Database Syst Rev. 2014 Jun 5;2014(6):CD002255. doi: 10.1002/14651858.CD002255.pub2.
PubMed 24901312de Heus R, Mulder EJ, Visser GH. Management of preterm labor: atosiban or nifedipine? Int J Womens Health. 2010 Aug 9;2:137-42. doi: 10.2147/ijwh.s7219.
PubMed 21072306Smith GN. What are the realistic expectations of tocolytics? BJOG. 2003 Apr;110 Suppl 20:103-6. doi: 10.1016/s1470-0328(03)00053-3.
PubMed 12763123
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tocolytic Efficacy of Nifedipine in the Management of Threatened and Advanced Preterm Labor: A Study on 444 Singleton Pregnant Women With Intact Membranes
- ClinicalTrials.gov ID
- NCT04644354
- Acronym / sponsor ID
- BOG/TH/PTL / BakirkoyDogumeviTez/2005
- Conditions
- Preterm Labor, Preterm Birth, Preterm Labor Without Delivery, Preterm Labor With Preterm Delivery in Third Trimester, Calcium-Channel Blockers Toxicity, Side Effect of Drug
- Keywords
- Nifedipine, Tocolytics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Ethem Unal, M.D., PhD, Associate Prof of Surgery & SurgicOther government
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 25 Nov 2020 (actual)
- 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.
Preterm labor is one of the problems of obstetrics, and is one of the leading cause of neonatal morbidity and mortality. The incidence of preterm birth is around 7 to 9 %. The preterm baby is prone to respiratory, renal, neurologic and gastrointestinal problems. The correct diagnosis should be followed by the early administration of the most effective tocolytic agent with least side effects for both mother and fetus. Nifedipine, a calcium channel blocker, has gained a world-wide popularity recently since it has the least side-effects on both mother and fetus. In the present study, we aimed to evaluate the success rate of tocolytic agent 'nifedipine' on the spontaneous preterm labor of singeton pregnant women with intact amnionic membrane.
Detailed description
Preterm birth is the main reason of perinatal morbidity and mortality. The main management method of this important problem is to prolong the pregnancy period and to use corticosteroids to prevent fetal pulmonary distress. The most widely studied tocolytic agents, ritodrin, salbutamol and terbutaline are all betamimetics, and they are shown to prolong birth labor till 7 days and do not have any effct on the fetal mortality. However, their maternal side-effects are inevitable and can be mortal. They cause tachycardia, hypotension and some biochemical disturbances. Furthermore, maternal death is possible due to pulmonary edema. These adrenergic agonists are the first line tocolytics, but calcium canal blockers are becoming more popular since they have less side effects and comparable efficacy.
Calcium canal blockers are nonspecific smooth muscle relaxants used in adult hypertension treatment. Their tocolytic effect depends on their inhibition of calcium ions into the myometrial cells. In vitro studies have shown that they have strong relaxant effects on human myometrium. In the present study, our aim is to investigate the effects of nifedipine in our clinic in a period between 2002 and 2005, when it was first used in our clinic as the sıngle tocolytic agent. Its success in preventing preterm labor and its complications in our earlier practice will be noted and this retrospective study will guide us in its current usage, dosages and side-effects.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Advanced Preterm Labor (aPL) | – | Drug: Nifedipine 10 mgSingleton pregnant women with spontaneous preterm labor at their 23-36 weeks: regular contractions 4 or more in 20 minutes and cervical dilatation at 2 cm and above |
| Group B - Threatened Preterm Labor (tPL) | – | Drug: Nifedipine 10 mgSingleton pregnant women with spontaneous preterm labor at their 23-36 weeks: regular contractions less then 4 in 20 minutes and cervical dilatation less then 2 cm |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Only pregnant women (23-37 weeks) with preterm labor
Key inclusion criteria (1 listed)
- ingleton pregnant women with spontaneous preterm labor at their 23-37 weeks.
Key exclusion criteria (3 listed)
- Normal pregnant women
- Pregnent women before 23 weeks of gestation
- Pregant women between 23 and 37 weeks of gestation, but with preterm early membrane rupture, chorioamnionitis, preterm labor without cervical change, multiple pregnancy, hypertension, intrauterine growth retardation, fetal anomaly, oligoanhidramniosis, placenta previa, decolman placentaand intrauterine fetal death
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 |
|---|---|---|
| Nifedipine 10 mgFor both groups, when preterm labor is diagnosed, 10 mg capsule will be given sublinguially and if it is not effective in 1 hour, the same dose will be repeated again, and the same regimen will be repeated every day till preterm labor ends or proceed to a preterm birth. | Drug | Group A - Advanced Preterm Labor (aPL), Group B - Threatened Preterm Labor (tPL) |
Primary outcome
Delay Delivery for 1 day
Time frame: 1 day
After start of tocolytic nifedipine, the delay recorded till delivery is only 24 hours
Delay Delivery for 2 days
Time frame: 2 days
After start of tocolytic nifedipine, the delay recorded till delivery is 48 hours
Delay Delivery for 3 days
Time frame: 3 days
After start of tocolytic nifedipine, the delay recorded till delivery is 72 hours
Delay Delivery for 7 days
Time frame: 7 days
After start of tocolytic nifedipine, the delay recorded till delivery is 168 hours
Birth before 34 weeks
Time frame: till 34 weeks of gestation
After start of tocolytic nifedipine, the preterm birth occurs before 34 weeks
Birth before 37 weeks
Time frame: till 37 weeks of gestation
After start of tocolytic nifedipine, the preterm birth occurs before 37 weeks
Birth after 37weeks
Time frame: after 37 weeks of gestation-normal birth
After start of tocolytic nifedipine, the preterm birth occurs after 37 weeks (Normal birth)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Background: PubMed 24901312Flenady V, Wojcieszek AM, Papatsonis DN, Stock OM, Murray L, Jardine LA, Carbonne B. Calcium channel blockers for inhibiting preterm labour and birth. Cochrane Database Syst Rev. 2014 Jun 5;2014(6):CD002255. doi: 10.1002/14651858.CD002255.pub2.
- Background: PubMed 21072306de Heus R, Mulder EJ, Visser GH. Management of preterm labor: atosiban or nifedipine? Int J Womens Health. 2010 Aug 9;2:137-42. doi: 10.2147/ijwh.s7219.
- Background: PubMed 12763123Smith GN. What are the realistic expectations of tocolytics? BJOG. 2003 Apr;110 Suppl 20:103-6. doi: 10.1016/s1470-0328(03)00053-3.
- Principal sponsor IDLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data will be available at Excel file and be shared by email upon any request.
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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.
Aysun Firat, M.D., Specialist of Obstetrics&Gynecology, Dir principal investigator
Study Director
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor and Preterm Birth, run by Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Nov 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysun Firat, M.D., Specialist of Obstetrics&Gynecology (+90 (532) 5462332, aysunfirat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay Delivery for 1 day (time frame: 1 day). The study lists 7 primary outcomes in all. 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 NCT04644354, which also lists 3 linked publications.
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 25 Nov 2020.