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

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 3

Conditions: Pregnancy

Treatments: Drug: Placebo; Drug: Dydrogesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT02128685

UW 13-292

Details and patient eligibility

About

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.

Enrollment: 406 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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406 participants in 2 patient groups, including a placebo group

Dydrogesterone

Active Comparator group

Description:

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.

Treatment:

Drug: Dydrogesterone

Placebo pill

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo