Clinical trial NCT02128685: Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Threatened Miscarriage
Official title: A Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Keywords: Threatened miscarriage
Dydrogesterone
Randomized controlled trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 406
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The chance of miscarriage before 20 weeks of gestation
timeFrame: At 20 weeks of gestation
Secondary outcomes:
measure: Live birth rate
timeFrame: At the time of delivery, from 24 weeks of gestation till term gestation
measure: The proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (<20 weeks)
timeFrame: Before 20 weeks of gestation
measure: The incidence of antepartum hemorrhage
timeFrame: From 24 weeks of gestation till term
measure: The incidence of placenta previa
timeFrame: From 24 weeks of gestation till term
measure: The incidence of pregnancy-induced hypertension
timeFrame: From 20 weeks of gestation till term
measure: The incidence of intrauterine death
timeFrame: After 24 weeks of gestation till term
measure: The incidence of preterm labour
timeFrame: From 24 weeks to 36 weeks gestation
measure: Low birth weight at term (grams)
timeFrame: After 37 weeks gestation
Other outcomes:
Locations:
city: Chai Wan
country: Hong Kong
facility: Department of Obstetrics and Gynaecology, PYNEH
city: Hong Kong
country: Hong Kong
facility: Department of Obstetrics & Gynaecology, Queen Mary Hospital
city: Mong Kok
country: Hong Kong
facility: Department of Obstetrics & Gynaecology, Kwong Wah Hospital
Study officials:
affiliation: Department of Obstetrics & Gynaecology, Queen Mary Hospital
name: Man Ka Diana Chan, MBBS(HK)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.