Pregnancy
Conditions
Keywords
Threatened miscarriage, Dydrogesterone, Randomized controlled trial
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.
Interventions
DRUGDydrogesterone
DRUGPlacebo
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The chance of miscarriage before 20 weeks of gestation | At 20 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of placenta previa | From 24 weeks of gestation till term | Placenta is being inserted partially or wholly in the lower uterine segment and will be diagnosed by antenatal ultrasound at second and third trimesters |
| 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 | — |
| The incidence of antepartum hemorrhage | From 24 weeks of gestation till term | Any vaginal bleeding during pregnancy from the 24th week gestational age to term |
| The incidence of intrauterine death | After 24 weeks of gestation till term | Fetus dies in uterus after 24 weeks gestation |
| The incidence of preterm labour | From 24 weeks to 36 weeks gestation | Any premature spontaneous delivery from 24 weeks to 36 weeks gestation |
| Low birth weight at term (grams) | After 37 weeks gestation | Baby born with birth weight less than 2500g at or after 37 weeks gestation |
| The incidence of pregnancy-induced hypertension | From 20 weeks of gestation till term | 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 |
Countries
Hong Kong
Outcome results
None listed