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.

Phase 1

Conditions: Threatened abortion
MedDRA version: 20.1Level: PTClassification code 10000242Term: Abortion threatenedSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
MedDRA version: 20.0Level: PTClassification code 10063273Term: Progesterone normalSystem Organ Class: 10022891 - Investigations
MedDRA version: 20.0Level: PTClassification code 10063291Term: ProgesteroneSystem Organ Class: 10022891 - Investigations
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2016-002777-35-IT

Lead Sponsor: IBSA INSTITUT BIOCHIMIQUE SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 268

Inclusion Criteria

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

Exclusion Criteria

-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.