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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dydrogesterone | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The chance of miscarriage before 20 weeks of gestation | At 20 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | 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) | Before 20 weeks of gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Man Ka Diana Chan, MBBS(HK) | Department of Obstetrics & Gynaecology, Queen Mary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynaecology, PYNEH | Chai Wan | Hong Kong | ||||
| Department of Obstetrics & Gynaecology, Queen Mary Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33331637 | Derived | 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. | |
| 27534747 | Derived | Chan 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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| ID | Term |
|---|---|
| D000033 | Abortion, Threatened |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
|
| The incidence of antepartum hemorrhage | Any vaginal bleeding during pregnancy from the 24th week gestational age to term | 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 | 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 | From 20 weeks of gestation till term |
| The incidence of intrauterine death | Fetus dies in uterus after 24 weeks gestation | After 24 weeks of gestation till term |
| The incidence of preterm labour | Any premature spontaneous delivery from 24 weeks to 36 weeks gestation | 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 | After 37 weeks gestation |
| Hong Kong |
| Hong Kong |
| Department of Obstetrics & Gynaecology, Kwong Wah Hospital | Mong Kok | Hong Kong |
| D011083 |
| Polycyclic Compounds |