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

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ClinicalTrials.gov Identifier: NCT02128685
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Diana Man-Ka Chan, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Dydrogesterone Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester
Study Start Date : March 2016
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Arm Intervention/treatment
Active Comparator: Dydrogesterone
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.
Drug: Dydrogesterone
Other Name: Duphaston

Placebo Comparator: Placebo pill
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.
Drug: Placebo



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

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128685


Locations
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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, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Man Ka Diana Chan, MBBS(HK) Department of Obstetrics & Gynaecology, Queen Mary Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Diana Man-Ka Chan, Resident, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02128685     History of Changes
Other Study ID Numbers: UW 13-292
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Keywords provided by Dr. Diana Man-Ka Chan, The University of Hong Kong:
Threatened miscarriage
Dydrogesterone
Randomized controlled trial

Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Threatened
Pregnancy Complications
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs