The Efficacy of Nifedipine in the Management of Preterm Labor (NCT04644354) | Clinical Trial Compass
UnknownNot Applicable
The Efficacy of Nifedipine in the Management of Preterm Labor
444 participantsStarted 2020-12-15
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Delay Delivery for 1 day
Timeframe: 1 day
2
Delay Delivery for 2 days
Timeframe: 2 days
3
Delay Delivery for 3 days
Timeframe: 3 days
4
Delay Delivery for 7 days
Timeframe: 7 days
5
Birth before 34 weeks
Timeframe: till 34 weeks of gestation
6
Birth before 37 weeks
Timeframe: till 37 weeks of gestation
7
Birth after 37weeks
Timeframe: after 37 weeks of gestation-normal birth
Trial details
NCT IDNCT04644354
SponsorEthem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
Sponsor typeOTHER_GOV
Study typeOBSERVATIONAL
Primary completion2020-12-20
Contact for this trial
Aysun Firat, M.D., Specialist of Obstetrics&Gynecology