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

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Dydrogesterone

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