PregnancyPhase 3NCT02128685
Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Threatened Miscarriage
A Phase 3 study testing Dydrogesterone in people with Pregnancy, run by The University of Hong Kong at 3 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Dydrogesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 3 sitesHong Kong
- Study dates
- Mar 2016to 31 May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Department of Obstetrics and Gynaecology, PYNEH
Chai Wan
Department of Obstetrics & Gynaecology, Queen Mary Hospital
Hong Kong
Department of Obstetrics & Gynaecology, Kwong Wah Hospital
Mong Kok
About this study
Official title: A Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester
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.
- Conditions
- Pregnancy
- Being tested
- Dydrogesterone, Placebo
- Keywords
- Threatened miscarriage, Dydrogesterone, Randomized controlled trial
- Medical subject headings
- Abortion, Threatened
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DydrogesteroneDrug
Also called Duphaston
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dydrogesterone | Active comparator | Patients allocated to the dydrogesterone group will receive oral dydrogesterone 40mg stat, followed by 10mg orally three times a day, and placebo will be used in the control group accordingly. Patients will be followed up with weekly pelvic ultrasound till 12 completed weeks of gestation or 1 week after the bleeding stopped, whichever is longer. Receives: Drug: Dydrogesterone |
| Placebo pill | Placebo comparator | Patients allocated to the dydrogesterone group will receive oral dydrogesterone 40mg stat, followed by 10mg orally three times a day, and placebo will be used in the control group accordingly. Patients will be followed up with weekly pelvic ultrasound till 12 completed weeks of gestation or 1 week after the bleeding stopped, whichever is longer. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The chance of miscarriage before 20 weeks of gestation
Measured: At 20 weeks of gestation
Secondary outcomes (8)
Live birth rate
Measured: At the time of delivery, from 24 weeks of gestation till term gestation
The proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (<20 weeks)
Measured: Before 20 weeks of gestation
The incidence of antepartum hemorrhage
Any vaginal bleeding during pregnancy from the 24th week gestational age to term
Measured: From 24 weeks of gestation till term
The incidence of placenta previa
Placenta is being inserted partially or wholly in the lower uterine segment and will be diagnosed by antenatal ultrasound at second and third trimesters
Measured: From 24 weeks of gestation till term
The incidence of pregnancy-induced hypertension
Any development of newly-onset hypertension (blood pressure persistently >=140/90mmHg on two occasions at least 4 hours apart) during pregnancy after 20 weeks gestation, labour or the puerperium in a previously normotensive non-proteinuric women
Measured: From 20 weeks of gestation till term
The incidence of intrauterine death
Fetus dies in uterus after 24 weeks gestation
Measured: After 24 weeks of gestation till term
The incidence of preterm labour
Any premature spontaneous delivery from 24 weeks to 36 weeks gestation
Measured: From 24 weeks to 36 weeks gestation
Low birth weight at term (grams)
Baby born with birth weight less than 2500g at or after 37 weeks gestation
Measured: After 37 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startMar 2016
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Diana Man-Ka Chan, The University of Hong Kong
- Investigators
- Man Ka Diana Chan, MBBS(HK), Principal investigator, Department of Obstetrics & Gynaecology, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128685
- Sponsor's protocol ID
- UW 13-292
- Status last verified
- Oct 2018
- First submitted
- 29 Apr 2014
- Last updated
- 16 Oct 2018
- Results posted
- No
Publications
Chan DMK, Cheung KW, Ko JKY, Yung SSF, Lai SF, Lam MT, Ng DYT, Lee VCY, Li RHW, Ng EHY. Use of oral progestogen in women with threatened miscarriage in the first trimester: a randomized double-blind controlled trial. Hum Reprod. 2021 Feb 18;36(3):587-595. doi: 10.1093/humrep/deaa327.
PubMed 33331637Chan DM, Cheung KW, Yung SS, Lee VC, Li RH, Ng EH. A randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial. Trials. 2016 Aug 17;17(1):408. doi: 10.1186/s13063-016-1509-8.
PubMed 27534747
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester
- ClinicalTrials.gov ID
- NCT02128685
- Acronym / sponsor ID
- UW 13-292
- Conditions
- Pregnancy
- Keywords
- Threatened miscarriage, Dydrogesterone, Randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dydrogesterone | Active comparator | Drug: DydrogesteronePatients allocated to the dydrogesterone group will receive oral dydrogesterone 40mg stat, followed by 10mg orally three times a day, and placebo will be used in the control group accordingly. Patients will be followed up with weekly pelvic ultrasound till 12 completed weeks of gestation or 1 week after the bleeding stopped, whichever is longer. |
| Placebo pill | Placebo comparator | Drug: PlaceboPatients allocated to the dydrogesterone group will receive oral dydrogesterone 40mg stat, followed by 10mg orally three times a day, and placebo will be used in the control group accordingly. Patients will be followed up with weekly pelvic ultrasound till 12 completed weeks of gestation or 1 week after the bleeding stopped, whichever is longer. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DydrogesteroneAlso: Duphaston | Drug | Dydrogesterone |
| Placebo | Drug | Placebo pill |
Primary outcome
The chance of miscarriage before 20 weeks of gestation
Time frame: At 20 weeks of gestation
8 secondary outcomes
Live birth rate
Time frame: At the time of delivery, from 24 weeks of gestation till term gestation
The proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (<20 weeks)
Time frame: Before 20 weeks of gestation
The incidence of antepartum hemorrhage
Time frame: From 24 weeks of gestation till term
The incidence of placenta previa
Time frame: From 24 weeks of gestation till term
The incidence of pregnancy-induced hypertension
Time frame: From 20 weeks of gestation till term
The incidence of intrauterine death
Time frame: After 24 weeks of gestation till term
The incidence of preterm labour
Time frame: From 24 weeks to 36 weeks gestation
Low birth weight at term (grams)
Time frame: After 37 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Derived from this study: PubMed 33331637Chan DMK, Cheung KW, Ko JKY, Yung SSF, Lai SF, Lam MT, Ng DYT, Lee VCY, Li RHW, Ng EHY. Use of oral progestogen in women with threatened miscarriage in the first trimester: a randomized double-blind controlled trial. Hum Reprod. 2021 Feb 18;36(3):587-595. doi: 10.1093/humrep/deaa327.
- Derived from this study: PubMed 27534747Chan DM, Cheung KW, Yung SS, Lee VC, Li RH, Ng EH. A randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial. Trials. 2016 Aug 17;17(1):408. doi: 10.1186/s13063-016-1509-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Man Ka Diana Chan, MBBS(HK) principal investigator
Department of Obstetrics & Gynaecology, Queen Mary Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dydrogesterone in people with Pregnancy, run by The University of Hong Kong at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The chance of miscarriage before 20 weeks of gestation (time frame: At 20 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128685, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.