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

Primary Purpose

Pregnancy

Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Dydrogesterone
Placebo
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring Threatened miscarriage, Dydrogesterone, Randomized controlled trial

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Obstetrics and Gynaecology, PYNEH
  • Department of Obstetrics & Gynaecology, Queen Mary Hospital
  • Department of Obstetrics & Gynaecology, Kwong Wah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dydrogesterone

Placebo pill

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The chance of miscarriage before 20 weeks of gestation

Secondary Outcome Measures

Live birth rate
The proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (<20 weeks)
The incidence of antepartum hemorrhage
Any vaginal bleeding during pregnancy from the 24th week gestational age to 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
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
The incidence of intrauterine death
Fetus dies in uterus after 24 weeks gestation
The incidence of preterm labour
Any premature spontaneous delivery from 24 weeks to 36 weeks gestation
Low birth weight at term (grams)
Baby born with birth weight less than 2500g at or after 37 weeks gestation

Full Information

First Posted
April 29, 2014
Last Updated
October 15, 2018
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02128685
Brief Title
Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Threatened Miscarriage
Official Title
A Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Threatened miscarriage, Dydrogesterone, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dydrogesterone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo pill
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dydrogesterone
Other Intervention Name(s)
Duphaston
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The chance of miscarriage before 20 weeks of gestation
Time Frame
At 20 weeks of gestation
Secondary Outcome Measure Information:
Title
Live birth rate
Time Frame
At the time of delivery, from 24 weeks of gestation till term gestation
Title
The proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (<20 weeks)
Time Frame
Before 20 weeks of gestation
Title
The incidence of antepartum hemorrhage
Description
Any vaginal bleeding during pregnancy from the 24th week gestational age to term
Time Frame
From 24 weeks of gestation till term
Title
The incidence of placenta previa
Description
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
Title
The incidence of pregnancy-induced hypertension
Description
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
Title
The incidence of intrauterine death
Description
Fetus dies in uterus after 24 weeks gestation
Time Frame
After 24 weeks of gestation till term
Title
The incidence of preterm labour
Description
Any premature spontaneous delivery from 24 weeks to 36 weeks gestation
Time Frame
From 24 weeks to 36 weeks gestation
Title
Low birth weight at term (grams)
Description
Baby born with birth weight less than 2500g at or after 37 weeks gestation
Time Frame
After 37 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Man Ka Diana Chan, MBBS(HK)
Organizational Affiliation
Department of Obstetrics & Gynaecology, Queen Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynaecology, PYNEH
City
Chai Wan
Country
Hong Kong
Facility Name
Department of Obstetrics & Gynaecology, Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Department of Obstetrics & Gynaecology, Kwong Wah Hospital
City
Mong Kok
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
33331637
Citation
Chan DMK, Cheung KW, Ko JKY, Yung SSF, Lai SF, Lam MT, Ng DYT, Lee VCY, Li RHW, Ng EHY. Use of oral progestogen in women with threatened miscarriage in the first trimester: a randomized double-blind controlled trial. Hum Reprod. 2021 Feb 18;36(3):587-595. doi: 10.1093/humrep/deaa327.
Results Reference
derived
PubMed Identifier
27534747
Citation
Chan DM, Cheung KW, Yung SS, Lee VC, Li RH, Ng EH. A randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial. Trials. 2016 Aug 17;17(1):408. doi: 10.1186/s13063-016-1509-8.
Results Reference
derived

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

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