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CompletedNCT04788108Updated Aug 30, 2023

Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

A Phase 4 interventional study of Dydrogesterone and Placebo in Threatened Abortion, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Chulalongkorn University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Threatened Abortion

Keywords

  • threatened abortion
03

In context

Abortion, Spontaneous

320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.

This study's enrollment of 100 is below the median of 147 across 174 interventional studies indexed under Abortion, Spontaneous.

Browse Abortion, Spontaneous studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Dydrogesterone

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

    Drug: Dydrogesterone

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugDydrogesterone

    Dydrogesterone tablet

  • DrugPlacebo

    Placebo tablet

06

What researchers measure

Primary outcomes

  1. continue pregnancy more than 20 weeks gestation

    percentage of cases with continue pregnancy more than 20 weeks gestation

    Time frame: at 20 weeks gestation

Secondary outcomes

  1. preterm delivery less than 34 weeks

    percentage of delivery less than 34 weeks

    Time frame: at 34 weeks gestation

  2. preterm delivery less than 37 weeks

    percentage of delivery less than 37 weeks

    Time frame: at 37 weeks gestation

  3. placenta previa

    percentage of placenta previa

    Time frame: 31 weeks

  4. abruptio placenta

    percentage of abruptio placenta

    Time frame: 31 weeks

  5. Intrauterine growth restriction

    percentage of intrauterine growth restriction

    Time frame: 31 weeks

  6. neonatal complications

    percentage of newborn with respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, death

    Time frame: 31 weeks

  7. side effects

    percentage of side effects such as headache, nausea/vomiting

    Time frame: 6 weeks

  8. compliance

    percentage of complete drug use

    Time frame: 6 weeks

  9. maternal satisfaction

    percentage of good satisfaction

    Time frame: 6 weeks

  10. time until bleeding stops

    time from first bleeding until bleeding stops

    Time frame: 6 weeks

07

Study locations

1 site
  • Faculty of Medicine, Chulalongkorn University
    Bangkok, 10330, Thailand
08

References and documents

Publications

  • 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. PubMed 30157093 ↗
  • 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. PubMed 26800266 ↗
  • 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. PubMed 14670641 ↗
  • 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. PubMed 16293412 ↗
  • 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. PubMed 20005647 ↗
  • 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. PubMed 20007011 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04788108
Lead sponsor
Chulalongkorn University
Responsible party
Vorapong Phupong (Head of Placental Related Diseases Research Unit, Principal Investigator, Professor, Chulalongkorn University) — Principal investigator
First posted
Mar 9, 2021
Start date
Aug 1, 2021
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Aug 30, 2023

Study contacts

Vorapong Phupong, M.D.
study director · Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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