Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT02950935
Eligibility Criteria:
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 , with or without 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;
* At the first case of threatened abortion in the current pregnancy.
Exclusion Criteria:
* Pregnancy obtained via ART treatment;
* Subchorionic haematoma with \>50% placental detachment;
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
37 Years
Study:
NCT02950935
Study Brief:
Protocol Section:
NCT02950935