Skip to main content
OpenTrials
Completed

NCT Number: NCT02128685

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Abortion, Threatened Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Department of Obstetrics and Gynaecology, PYNEH, Chai Wan, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dydrogesterone

Drug

Other names: Duphaston

Placebo

Drug

Primary outcomes

  1. The chance of miscarriage before 20 weeks of gestation

    Time frame: At 20 weeks of gestation

Secondary outcomes

  1. Live birth rate

    Time frame: At the time of delivery, from 24 weeks of gestation till term gestation

  2. The proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (<20 weeks)

    Time frame: Before 20 weeks of gestation

  3. The incidence of antepartum hemorrhage

    Time frame: From 24 weeks of gestation till term

    Any vaginal bleeding during pregnancy from the 24th week gestational age to term

  4. The incidence of placenta previa

    Time frame: 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

  5. The incidence of pregnancy-induced hypertension

    Time frame: 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

  6. The incidence of intrauterine death

    Time frame: After 24 weeks of gestation till term

    Fetus dies in uterus after 24 weeks gestation

  7. The incidence of preterm labour

    Time frame: From 24 weeks to 36 weeks gestation

    Any premature spontaneous delivery from 24 weeks to 36 weeks gestation

  8. Low birth weight at term (grams)

    Time frame: After 37 weeks gestation

    Baby born with birth weight less than 2500g at or after 37 weeks gestation

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

A Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 1, 2014
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.