The Efficacy of Nifedipine in the Management of Preterm Labor

Preterm Birth Clinical Trial

— BOG/TH/PTL  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04644354
• Other study ID #: BakirkoyDogumeviTez/2005
• Status: Not yet recruiting
• Start date: December 15, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: November 2020
• Source: Umraniye Education and Research Hospital
• Contact: Aysun Firat, M.D., Specialist of Obstetrics&Gynecology
• Phone: +90 (532) 5462332
• Email: aysunfirat[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 444
• Est. completion date: December 30, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Calcium-Channel Blockers Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth
• Preterm Labor
• Preterm Labor With Preterm Delivery in Third Trimester
• Preterm Labor Without Delivery
• Side Effect of Drug

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

References & Publications (3)

de Heus R, Mulder EJ, Visser GH. Management of preterm labor: atosiban or nifedipine? Int J Womens Health. 2010 Aug 9;2:137-42. — View Citation

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;(6):CD002255. doi: 10.1002/14651858.CD002255.pub2. Review. — View Citation

Smith GN. What are the realistic expectations of tocolytics? BJOG. 2003 Apr;110 Suppl 20:103-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delay Delivery for 1 day	After start of tocolytic nifedipine, the delay recorded till delivery is only 24 hours	1 day
Primary	Delay Delivery for 2 days	After start of tocolytic nifedipine, the delay recorded till delivery is 48 hours	2 days
Primary	Delay Delivery for 3 days	After start of tocolytic nifedipine, the delay recorded till delivery is 72 hours	3 days
Primary	Delay Delivery for 7 days	After start of tocolytic nifedipine, the delay recorded till delivery is 168 hours	7 days
Primary	Birth before 34 weeks	After start of tocolytic nifedipine, the preterm birth occurs before 34 weeks	till 34 weeks of gestation
Primary	Birth before 37 weeks	After start of tocolytic nifedipine, the preterm birth occurs before 37 weeks	till 37 weeks of gestation
Primary	Birth after 37weeks	After start of tocolytic nifedipine, the preterm birth occurs after 37 weeks (Normal birth)	after 37 weeks of gestation-normal birth

External Links

•   Principal sponsor ID