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

Phase 3

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo pill	Placebo	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.
Dydrogesterone	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.

Primary Outcome Measures

Name	Time	Method
The chance of miscarriage before 20 weeks of gestation	At 20 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
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	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
The incidence of intrauterine death	After 24 weeks of gestation till term	Fetus dies in uterus after 24 weeks gestation
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	Placenta is being inserted partially or wholly in the lower uterine segment and will be diagnosed by antenatal ultrasound at second and third trimesters
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 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

Locations (3): Department of Obstetrics and Gynaecology, PYNEH
🇭🇰
Chai Wan, Hong Kong
Department of Obstetrics & Gynaecology, Queen Mary Hospital
🇭🇰
Hong Kong, Hong Kong
Department of Obstetrics & Gynaecology, Kwong Wah Hospital
🇭🇰
Mong Kok, Hong Kong