Evaluating the Use of a Progesterone Receptor Modulator for Cervical Ripening at Full Term Pregnancy – a Randomized, Double-blind , placebo controlled Study (LUCYNA) - LUCYNA

Disphar International B.V0 个研究点目标入组 150 人开始时间: 2019年6月11日最近更新: 2022年5月2日

试验速览

暂无简介。

•Age 18 – 40 years
•Pregnancy = 40 Weeks + 5 days
•Bishop Score = 5
•Intact membranes
•BMI = 30 before pregnancy
•Primiparous women
•Singleton pregnancy
•Physiological pregnancy (no risk factors, no abnormalities in clinical and laboratory examinations during pregnancy)
•Agreeing to participate in the study
•Signed written informed consent for study participation
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•any contraindication to vaginal delivery
•previous late abortion (= 12 week of pregnancy)
•uterine scar
•cephalopelvic disproportion
•placenta praevia
•fetal malpresentation
•chorioamnionitis
•fetal congenital abnormalities
•participation in a clinical trial with investigational drugs within the last 3 months before the enrolment or during the present trial period.
•significant maternal cardiac, renal or hepatic disease or any condition,which in the opinion of the Investigator place the patient at an unacceptable risk level for participating in a study

发起方

Disphar International B.V