Progesterone in Threatened Abortion (NCT02950935) | Clinical Trial Compass
TerminatedPhase 3
Progesterone in Threatened Abortion
Stopped: Difficulty in recruitment
Italy4 participantsStarted 2017-04-04
Plain-language summary
The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of threatened abortion. The secondary objectives will be the efficacy of progesterone in reducing both pain and uterine contractions.
Who can participate
Age range18 Years – 37 Years
SexFEMALE
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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.