Prospective, double-blind, randomised, placebo controlled, phase III clinical study assessing the efficacy of natural progesterone 25 mg/bid administered subcutaneously in the maintenance of early pregnancy in women with symptoms of threatened abortion. - Progesterone (Pleyrys)

IBSA INSTITUT BIOCHIMIQUE SA0 个研究点目标入组 268 人开始时间: 2018年8月29日最近更新: 2018年9月17日

适应症

试验速览

暂无简介。

•Pregnant women attending the emergency room of the study sites with the following characteristics:
•- Able and willing to sign the Subject Informed Consent Form and adhere to the study visit schedule;
•- Age: 18-37 years;
•- BMI: 18-28 kg/m2;
•- Symptoms of threatened abortion (vaginal bleeding, pelvic pain);
•- Ultrasound proof of viable singleton intrauterine pregnancy (positive foetal heart beat);
•- Gestation week =6 weeks (5 w +1d) and <12 weeks (11 w + 1d) according to ultrasound dating (CRL);
•- Closed uterine cervix;
•- Subchorionic haematoma with < 50% placental detachment;
•- At the first case of threatened abortion in the current pregnancy.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Pregnancy obtained via ART treatment;
•-History of recurrent miscarriage;
•-Severe uterine malformations;
•-Known hypersensitivity to study medication;
•-Neoplasias (known or suspected breast or genital tract cancer);
•-Severe impairment of hepatic or renal function;
•-Use of concomitant medications that might interfere with study evaluations (other hormonal treatment or drugs affecting uterine contractility);
•-Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events;
•-Porphyria;
•-A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy;
•-Antiphospholipid syndrome;
•-Diabetes mellitus;
•-Known thyroid diseases or autoimmune conditions.

发起方