NCT04788108

Brief Summary

This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

March 2, 2021

Last Update Submit

August 28, 2023

Conditions

Threatened Abortion

Keywords

threatened abortion

Outcome Measures

Primary Outcomes (1)

  • continue pregnancy more than 20 weeks gestation

    percentage of cases with continue pregnancy more than 20 weeks gestation

    at 20 weeks gestation

Secondary Outcomes (10)

  • preterm delivery less than 34 weeks

    at 34 weeks gestation

  • preterm delivery less than 37 weeks

    at 37 weeks gestation

  • placenta previa

    31 weeks

  • abruptio placenta

    31 weeks

  • Intrauterine growth restriction

    31 weeks

  • +5 more secondary outcomes

Study Arms (2)

Dydrogesterone

ACTIVE COMPARATOR

dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.

Drug: Dydrogesterone

Placebo

PLACEBO COMPARATOR

placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.

Drug: Placebo

Interventions

DydrogesteroneDRUG

Dydrogesterone tablet

Dydrogesterone
PlaceboDRUG

Placebo tablet

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • singleton pregnancy with gestational age 6 - 20 weeks
  • threatened abortion
  • confirmed intrauterine pregnancy with a viable fetus by ultrasound

You may not qualify if:

  • history of recurrent miscarriage
  • having endocervical polyp
  • having infection such as pneumonia, pyelonephritis, septicemia
  • having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
  • having cancer
  • having coagulation defect
  • allergy to dydrogesterone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (6)

  • American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 200: Early Pregnancy Loss. Obstet Gynecol. 2018 Nov;132(5):e197-e207. doi: 10.1097/AOG.0000000000002899.

    PMID: 30157093BACKGROUND

  • Mirza FG, Patki A, Pexman-Fieth C. Dydrogesterone use in early pregnancy. Gynecol Endocrinol. 2016;32(2):97-106. doi: 10.3109/09513590.2015.1121982. Epub 2016 Jan 22.

    PMID: 26800266BACKGROUND

  • Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2003 Dec 10;46 Suppl 1:S7-S16. doi: 10.1016/j.maturitas.2003.09.014.

    PMID: 14670641BACKGROUND

  • Omar MH, Mashita MK, Lim PS, Jamil MA. Dydrogesterone in threatened abortion: pregnancy outcome. J Steroid Biochem Mol Biol. 2005 Dec;97(5):421-5. doi: 10.1016/j.jsbmb.2005.08.013. Epub 2005 Nov 15.

    PMID: 16293412RESULT

  • Pandian RU. Dydrogesterone in threatened miscarriage: a Malaysian experience. Maturitas. 2009 Dec;65 Suppl 1:S47-50. doi: 10.1016/j.maturitas.2009.11.016. Epub 2009 Dec 14.

    PMID: 20005647RESULT

  • El-Zibdeh MY, Yousef LT. Dydrogesterone support in threatened miscarriage. Maturitas. 2009 Dec;65 Suppl 1:S43-6. doi: 10.1016/j.maturitas.2009.11.013. Epub 2009 Dec 14.

    PMID: 20007011RESULT

MeSH Terms

Conditions

Abortion, Threatened

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Vorapong Phupong, M.D.

    Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Placental Related Diseases Research Unit, Principal Investigator, Professor

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 9, 2021

Study Start

August 1, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

TH(1)