- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04644354
The Efficacy of Nifedipine in the Management of Preterm Labor (BOG/TH/PTL)
The Tocolytic Efficacy of Nifedipine in the Management of Threatened and Advanced Preterm Labor: A Study on 444 Singleton Pregnant Women With Intact Membranes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Aysun Firat, M.D., Specialist of Obstetrics&Gynecology
- Phone Number: +90 (532) 5462332
- Email: aysunfirat@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ingleton pregnant women with spontaneous preterm labor at their 23-37 weeks.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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.
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delay Delivery for 1 day
Time Frame: 1 day
|
After start of tocolytic nifedipine, the delay recorded till delivery is only 24 hours
|
1 day
|
Delay Delivery for 2 days
Time Frame: 2 days
|
After start of tocolytic nifedipine, the delay recorded till delivery is 48 hours
|
2 days
|
Delay Delivery for 3 days
Time Frame: 3 days
|
After start of tocolytic nifedipine, the delay recorded till delivery is 72 hours
|
3 days
|
Delay Delivery for 7 days
Time Frame: 7 days
|
After start of tocolytic nifedipine, the delay recorded till delivery is 168 hours
|
7 days
|
Birth before 34 weeks
Time Frame: till 34 weeks of gestation
|
After start of tocolytic nifedipine, the preterm birth occurs before 34 weeks
|
till 34 weeks of gestation
|
Birth before 37 weeks
Time Frame: till 37 weeks of gestation
|
After start of tocolytic nifedipine, the preterm birth occurs before 37 weeks
|
till 37 weeks of gestation
|
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)
|
after 37 weeks of gestation-normal birth
|
Collaborators and Investigators
Investigators
- Principal Investigator: Aysun Firat, M.D., Specialist of Obstetrics&Gynecology, Dir, Study Director
Publications and helpful links
General 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.
- de 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.
- Smith GN. What are the realistic expectations of tocolytics? BJOG. 2003 Apr;110 Suppl 20:103-6. doi: 10.1016/s1470-0328(03)00053-3.
Helpful Links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pregnancy Complications
- Obstetric Labor Complications
- Premature Birth
- Drug-Related Side Effects and Adverse Reactions
- Obstetric Labor, Premature
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Nifedipine
Other Study ID Numbers
- BakirkoyDogumeviTez/2005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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