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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: The University of Hong Kong

Current Primary Outcome: The chance of miscarriage before 20 weeks of gestation [ Time Frame: At 20 weeks of gestation ]

Original Primary Outcome: The chance of miscarriage before 20 weeks of gestation [ Time Frame: 20 weeks of gestation ]

Current Secondary Outcome:

  • Live birth rate [ Time Frame: At the time of delivery, from 24 weeks of gestation till term gestation ]
  • The proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (<20 weeks) [ Time Frame: Before 20 weeks of gestation ]
  • 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
  • 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
  • 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
  • The incidence of intrauterine death [ Time Frame: After 24 weeks of gestation till term ]
    Fetus dies in uterus after 24 weeks gestation
  • 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
  • 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


Original Secondary Outcome: The incidences of antepartum hemorrhage, placenta previa, pregnancy-induced hypertension, intrauterine death, congenital abnormality, preterm labour (28-36 weeks), low birth weight at term (<2500g) and full term delivery [ Time Frame: Antenatal till delivery ]

Information By: The University of Hong Kong

Dates:
Date Received: April 29, 2014
Date Started: March 2016
Date Completion: May 2018
Last Updated: February 12, 2017
Last Verified: February 2017