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 sites268 target enrollmentAugust 29, 2018

Overview

No summary available.

Registry

who.int

Start Date

August 29, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•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.

•\-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;