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 range
18 Years – 37 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated early — can you tell me why it was stopped before completion, and what that means for how much we can trust the results about progesterone for threatened miscarriage?
2Since this was a Phase 3 trial measuring ongoing pregnancy rates at 12 weeks, is there enough data from this or similar studies to know whether progesterone actually helps in my situation, or is the evidence still uncertain?
3Given that this trial was terminated, are there other active or completed studies on progesterone for threatened miscarriage that you think are more relevant to my case?
4Is progesterone for threatened miscarriage already used as a standard treatment option outside of a trial, and would that be worth considering for me instead of waiting for more research?
5How would my specific situation — including how far along I am and any other factors — affect whether progesterone is even something worth discussing as a possibility for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.