Clinical trial NCT04644354: The Efficacy of Nifedipine in the Management of Preterm Labor
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-11-25
Enrollment: 444
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only pregnant women (23-37 weeks) with preterm labor

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delay Delivery for 1 day
timeFrame: 1 day
measure: Delay Delivery for 2 days
timeFrame: 2 days
measure: Delay Delivery for 3 days
timeFrame: 3 days
measure: Delay Delivery for 7 days
timeFrame: 7 days
measure: Birth before 34 weeks
timeFrame: till 34 weeks of gestation
measure: Birth before 37 weeks
timeFrame: till 37 weeks of gestation
measure: Birth after 37weeks
timeFrame: after 37 weeks of gestation-normal birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Study Director
name: Aysun Firat, M.D., Specialist of Obstetrics&Gynecology, Dir
role: PRINCIPAL_INVESTIGATOR
References:
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;2014(6):CD002255. doi: 10.1002/14651858.CD002255.pub2.
citation: 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.
citation: 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.