A Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 406
- Locations
- 3
- Primary Endpoint
- The chance of miscarriage before 20 weeks of gestation
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dydrogesterone
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.
Intervention: Dydrogesterone (Drug)
Placebo pill
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The chance of miscarriage before 20 weeks of gestation
Time Frame: At 20 weeks of gestation
Secondary Outcomes
- Live birth rate(At the time of delivery, from 24 weeks of gestation till term gestation)
- The incidence of pregnancy-induced hypertension(From 20 weeks of gestation till term)
- The incidence of intrauterine death(After 24 weeks of gestation till term)
- The proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (<20 weeks)(Before 20 weeks of gestation)
- The incidence of placenta previa(From 24 weeks of gestation till term)
- The incidence of antepartum hemorrhage(From 24 weeks of gestation till term)
- The incidence of preterm labour(From 24 weeks to 36 weeks gestation)
- Low birth weight at term (grams)(After 37 weeks gestation)
Investigators
Dr. Diana Man-Ka Chan
Resident
The University of Hong Kong