MedDataX Logo

The Efficacy of Nifedipine in the Management of Preterm Labor

NCT ID: NCT04644354

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

444 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-15

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Explore important study keywords that can help with search, categorization, and topic discovery.

Nifedipine Tocolytics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Nifedipine 10 mg

Intervention Type DRUG

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

Nifedipine 10 mg

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nifedipine 10 mg

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aysun Firat, M.D., Specialist of Obstetrics&Gynecology, Dir

Role: PRINCIPAL_INVESTIGATOR

Study Director

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aysun Firat, M.D., Specialist of Obstetrics&Gynecology

Role: CONTACT

Phone: +90 (532) 5462332

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24901312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21072306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12763123 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://scholar.google.com.tr/citations?user=6bFlCZwAAAAJ&hl=tr

Principal sponsor ID

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BakirkoyDogumeviTez/2005

Identifier Type: -

Identifier Source: org_study_id