CompletedPhase 3

Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Threatened Miscarriage

Hong Kong406 participantsStarted 2016-03

Plain-language summary

The aim of this study is to determine whether the dydrogesterone therapy is associated with reduction in miscarriage in women with first trimester threatened miscarriage. The hypothesis is that the dydrogesterone therapy will significantly reduce the risk of miscarriage in women with threatened miscarriage.

Who can participate

Age range

18 Years – 40 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: * Age of women from 18-40 years at the time of recruitment (not beyond 40th birthday) * Absence of fever * Gestation less than 12 completed weeks as defined by pelvic ultrasound * Presence of intrauterine gestational sac(s) if an urine pregnancy test is first positive within past 2 weeks * Presence of intrauterine fetus(es) with crown-rump length of \<7mm and no fetal pulsation, or presence of intrauterine fetus(es) with positive fetal heart pulsation confirmed on pelvic scanning Exclusion Criteria: * Age of women \>40 years at the time of recruitment * History of recurrent miscarriage defined as at least three consecutive spontaneous miscarriages * History of known parental chromosomal abnormalities * Heavy vaginal bleeding requiring surgical intervention * Severe abdominal pain requiring surgical intervention * Absence of cardiac pulsation in a fetal pole with crown-rump length of \>=7mm on transvaginal scanning * Use of hCG or progesterone treatment for threatened miscarriage prior to recruitment

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

The chance of miscarriage before 20 weeks of gestation

Timeframe: At 20 weeks of gestation

Trial details

NCT IDNCT02128685

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-31

View on ClinicalTrials.gov More Pregnancy trials