Completed

Dydrogesterone Therapy for First Trimester Threatened Miscarriage

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What is being tested

Dydrogesterone

+ Placebo

Drug
Who is being recruted

Abortion, Threatened+1

+ Urogenital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 40 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: March 2016
See protocol details

Summary

Principal SponsorThe University of Hong Kong
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2016

Actual date on which the first participant was enrolled.

This study focuses on women who experience threatened miscarriage during their first trimester. The main goal is to find out if a medication called dydrogesterone can help reduce the risk of miscarriage. Miscarriage is a common issue, and this research aims to explore new ways to support women during this challenging time, potentially improving pregnancy outcomes. In this study, participants receive dydrogesterone therapy. The effectiveness of this treatment is measured by observing the chance of miscarriage before the 20th week of pregnancy. This is a blind study, meaning neither the participants nor the researchers know who is receiving the treatment or a placebo. This approach helps ensure the results are unbiased and accurate.

Official TitleA Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester
NCT02128685
Principal SponsorThe University of Hong Kong
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

406 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Abortion, ThreatenedUrogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPregnancy Complications

Criteria

5 inclusion criteria required to participate
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
Show More Criteria
7 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Department of Obstetrics and Gynaecology, PYNEH

Chai Wan, Hong KongOpen Department of Obstetrics and Gynaecology, PYNEH in Google Maps
Suspended

Department of Obstetrics & Gynaecology, Queen Mary Hospital

Hong Kong, Hong Kong
Suspended

Department of Obstetrics & Gynaecology, Kwong Wah Hospital

Mong Kok, Hong Kong
Completed3 Study Centers
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