CompletedNot Applicable

Non-interventional Study of Therapy for Threatened Miscarriage

Russia1,241 participantsStarted 2017-10-16

Plain-language summary

Study the efficacy and safety of therapy for threatened miscarriage with medicinal products Utrogestan (micronized progesterone), 200 mg capsules (Besins Healthcare SA, Belgium), and Duphaston (Dydrogesterone), 10 mg coated tablets (Abbott Healthcare Products B.V., the Netherlands)

Who can participate

Age range

18 Years – 35 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: * Signed informed consent of the patient to participate in the study; * Women aged 18-35 years; * Progressive uterine pregnancy at the time of inclusion in the study from 8 to 22 full weeks; * Drawing pains in the lower abdomen, lumbar region; * Scanty blood discharge from the genital tract; * Palpitation of the fetus revealed by ultrasound; * Prescription by attending physician of Utrogestan or Duphaston, depending on chosen treatment tactics. A physician should decide on the therapy, as well as tactics of further management of pregnancy before the patient is enrolled in the study and regardless of it. Exclusion Criteria: * Stimulated ovulation, use of assisted reproductive technologies; * Abnormalities in the structure of the uterus; * Amputation of the cervix; * Uterine myoma with submucosal location of the node (a clinically significant size); * Karyotype anomalies of parents (if applicable); * Aneuploidy, anembrion, fetal malformations, as established causes of loss of previous pregnancies; * Congenital thrombophilia: factor V gene mutation (Leiden mutation), mutation of the prothrombin gene (if applicable); * Non-developing pregnancy; * Other clinically significant causes of miscarriage identified during examination (including but not limited to): pre-pregnancy diabetes, pre-pregnancy uncompensated thyroid dysfunction, history of malignant tumors or current tumors, psychiatric illnesses; * STDs at the time of inclusion in the study; * Administrat…

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

Prolongation of pregnancy

Timeframe: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)

Trial details

NCT IDNCT03309735

SponsorBesins Healthcare

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-12-22

View on ClinicalTrials.gov More Threatened Miscarriage trials