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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128685
• Other study ID #: UW 13-292
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: May 31, 2018

Study information

• Verified date: October 2018
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Abortion, Threatened
• Pregnancy

Intervention

Drug:
• Dydrogesterone

• Placebo

Locations

Country	Name	City	State
Hong Kong	Department of Obstetrics and Gynaecology, PYNEH	Chai Wan
Hong Kong	Department of Obstetrics & Gynaecology, Queen Mary Hospital	Hong Kong
Hong Kong	Department of Obstetrics & Gynaecology, Kwong Wah Hospital	Mong Kok

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The chance of miscarriage before 20 weeks of gestation		At 20 weeks of gestation
Secondary	Live birth rate		At the time of delivery, from 24 weeks of gestation till term gestation
Secondary	The proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (<20 weeks)		Before 20 weeks of gestation
Secondary	The incidence of antepartum hemorrhage	Any vaginal bleeding during pregnancy from the 24th week gestational age to term	From 24 weeks of gestation till term
Secondary	The incidence of placenta previa	Placenta is being inserted partially or wholly in the lower uterine segment and will be diagnosed by antenatal ultrasound at second and third trimesters	From 24 weeks of gestation till term
Secondary	The incidence of pregnancy-induced hypertension	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	From 20 weeks of gestation till term
Secondary	The incidence of intrauterine death	Fetus dies in uterus after 24 weeks gestation	After 24 weeks of gestation till term
Secondary	The incidence of preterm labour	Any premature spontaneous delivery from 24 weeks to 36 weeks gestation	From 24 weeks to 36 weeks gestation
Secondary	Low birth weight at term (grams)	Baby born with birth weight less than 2500g at or after 37 weeks gestation	After 37 weeks gestation