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

The University of Hong Kong406 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

406

Conditions

Pregnancy

Interventions

DydrogesteroneDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (3)

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, Hong Kong

Outcomes

Primary Outcomes

The chance of miscarriage before 20 weeks of gestation

Time frame: At 20 weeks of gestation

Secondary Outcomes

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

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

Time frame: From 24 weeks of gestation till term

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

Time frame: From 24 weeks of gestation till term

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

Time frame: From 20 weeks of gestation till term

The incidence of intrauterine death

Fetus dies in uterus after 24 weeks gestation

Time frame: After 24 weeks of gestation till term

The incidence of preterm labour

Any premature spontaneous delivery from 24 weeks to 36 weeks gestation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.