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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

Ongoing pregnancy rate at 12 weeks of gestation

Timeframe: 12 weeks

Trial details

NCT IDNCT02950935

SponsorIBSA Institut Biochimique SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-02

View on ClinicalTrials.gov More Threatened Abortion in First Trimester trials