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临床试验/NCT04644354
NCT04644354Unknown不适用

The Tocolytic Efficacy of Nifedipine in the Management of Threatened and Advanced Preterm Labor: A Study on 444 Singleton Pregnant Women With Intact Membranes

Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic0 个研究点目标入组 444 人开始时间: 2020年12月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
444
主要终点
Delay Delivery for 1 day

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • ingleton pregnant women with spontaneous preterm labor at their 23-37 weeks.

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Nifedipine 10 mg (Drug)

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

干预措施: Nifedipine 10 mg (Drug)

结局指标

主要结局

Delay Delivery for 1 day

时间窗: 1 day

After start of tocolytic nifedipine, the delay recorded till delivery is only 24 hours

Delay Delivery for 2 days

时间窗: 2 days

After start of tocolytic nifedipine, the delay recorded till delivery is 48 hours

Delay Delivery for 3 days

时间窗: 3 days

After start of tocolytic nifedipine, the delay recorded till delivery is 72 hours

Delay Delivery for 7 days

时间窗: 7 days

After start of tocolytic nifedipine, the delay recorded till delivery is 168 hours

Birth before 34 weeks

时间窗: till 34 weeks of gestation

After start of tocolytic nifedipine, the preterm birth occurs before 34 weeks

Birth before 37 weeks

时间窗: till 37 weeks of gestation

After start of tocolytic nifedipine, the preterm birth occurs before 37 weeks

Birth after 37weeks

时间窗: after 37 weeks of gestation-normal birth

After start of tocolytic nifedipine, the preterm birth occurs after 37 weeks (Normal birth)

次要结局

未报告次要终点

研究者

发起方
Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

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

MD

Umraniye Education and Research Hospital

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