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

NCT02128685 | Completed Phase 3

• 1 other identifier: UW 13-292
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 3

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.

Conditions

Pregnancy

Keywords

Threatened miscarriage; Dydrogesterone; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• The chance of miscarriage before 20 weeks of gestation

  At 20 weeks of gestation

Secondary Outcomes (8)

• Live birth rate

  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)

  Before 20 weeks of gestation

• The incidence of antepartum hemorrhage

  From 24 weeks of gestation till term

• The incidence of placenta previa

  From 24 weeks of gestation till term

• The incidence of pregnancy-induced hypertension

  From 20 weeks of gestation till term

Study Arms (2)

Dydrogesterone

ACTIVE COMPARATOR

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

Placebo pill

PLACEBO COMPARATOR

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

Interventions

Dydrogesterone DRUG

Also known as: Duphaston

Dydrogesterone

Placebo DRUG

Placebo pill

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (3)

Department of Obstetrics and Gynaecology, PYNEH

Chai Wan, Hong Kong

Location

Department of Obstetrics & Gynaecology, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Department of Obstetrics & Gynaecology, Kwong Wah Hospital

Mong Kok, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 33331637 DERIVED

• 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.

  PMID: 27534747 DERIVED

MeSH Terms

Conditions

Abortion, Threatened

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Man Ka Diana Chan, MBBS(HK)

  Department of Obstetrics & Gynaecology, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: March 1, 2016
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

HK (3)