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CompletedNCT03935152Updated Jan 22, 2021

Oral Dydrogesterone in the Management of Preterm Labor

A Phase 4 interventional study of Dydrogesterone and placebo in Preterm Labor, 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 2021-01-22.

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

Phase
Phase 4
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

This study evaluates the addition of oral dydrogesterone to standard treatment in the treatment of preterm labor. Half of participants will receive oral dydrogesterone and standard treatment, while the other half will receive oral placebo and standard treatment.

02

Conditions studied

  • Preterm Labor
03

In context

Premature Birth

2,553 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 48 is below the median of 84 across 1,688 interventional studies indexed under Premature Birth.

Browse Premature Birth 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 24-33 weeks 6 days
  • preterm labor
  • received treatment with tocolysis and corticosteroids

Exclusion criteria

Exclusion Criteria:

  • conditions that need immediate delivery such as fetal distress, chorioamnionitis
  • have medical complications such as heart disease, seizure
  • fetal anomalies
  • cervical dilatation more than 5 cm
  • allergy to dydrogesterone
05

Study design

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

Study arms

  • Active comparator
    Dydrogesterone

    dydrogesterone 10 mg by mouth every 8 hours until delivery

    Drug: Dydrogesterone

  • Placebo comparator
    Placebo

    placebo by mouth every 8 hours until delivery

    Drug: placebo

Interventions

  • DrugDydrogesterone

    dydrogesterone capsule

  • Drugplacebo

    placebo capsule

06

What researchers measure

Primary outcomes

  1. latency period

    time from preterm labor to delivery

    Time frame: 13 weeks

Secondary outcomes

  1. preterm delivery less than 34 weeks

    percentage of delivery less than 34 weeks

    Time frame: 10 weeks

  2. preterm delivery less than 37 weeks

    percentage of delivery less than 37 weeks

    Time frame: 13 weeks

  3. neonatal complications

    percentage of newborn with RDS, IVH, NEC, death

    Time frame: 13 weeks

  4. side effects

    percentage of side effects such as headache, nausea/vomiting

    Time frame: 13 weeks

  5. compliance

    percentage of complete drug use

    Time frame: 13 weeks

  6. satisfaction

    percentage of good satisfaction

    Time frame: 13 weeks

  7. Time to the recurrence of uterine contractions

    Time to the recurrence of uterine contractions

    Time frame: 13 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-Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi: 10.1097/AOG.0000000000001711. PubMed 27661654 ↗
  • Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15. PubMed 24625129 ↗
  • Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72. PubMed 22102929 ↗
  • Yasuda K, Sumi GI, Murata H, Kida N, Kido T, Okada H. The steroid hormone dydrogesterone inhibits myometrial contraction independently of the progesterone/progesterone receptor pathway. Life Sci. 2018 Aug 15;207:508-515. doi: 10.1016/j.lfs.2018.07.004. Epub 2018 Jul 4. PubMed 29981319 ↗
  • Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2008 Sep-Oct;61(1-2):171-80. doi: 10.1016/j.maturitas.2008.11.013. PubMed 19434889 ↗
  • Borna S, Sahabi N. Progesterone for maintenance tocolytic therapy after threatened preterm labour: a randomised controlled trial. Aust N Z J Obstet Gynaecol. 2008 Feb;48(1):58-63. doi: 10.1111/j.1479-828X.2007.00803.x. PubMed 18275573 ↗
  • Arikan I, Barut A, Harma M, Harma IM. Effect of progesterone as a tocolytic and in maintenance therapy during preterm labor. Gynecol Obstet Invest. 2011;72(4):269-73. doi: 10.1159/000328719. Epub 2011 Nov 12. PubMed 22086108 ↗
  • Choudhary M, Suneja A, Vaid NB, Guleria K, Faridi MM. Maintenance tocolysis with oral micronized progesterone for prevention of preterm birth after arrested preterm labor. Int J Gynaecol Obstet. 2014 Jul;126(1):60-3. doi: 10.1016/j.ijgo.2014.01.019. Epub 2014 Apr 3. PubMed 24807871 ↗
  • Areeruk W, Phupong V. A randomized, double blinded, placebo controlled trial of oral dydrogesterone supplementation in the management of preterm labor. Sci Rep. 2016 Feb 9;6:20638. doi: 10.1038/srep20638. PubMed 26856618 ↗
  • Thongchan S, Phupong V. Oral dydrogesterone as an adjunctive therapy in the management of preterm labor: a randomized, double blinded, placebo-controlled trial. BMC Pregnancy Childbirth. 2021 Jan 28;21(1):90. doi: 10.1186/s12884-021-03562-6. PubMed 33509129 ↗

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 Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03935152
Lead sponsor
Chulalongkorn University
Responsible party
Vorapong Phupong (Professor, Chulalongkorn University) — Principal investigator
First posted
May 2, 2019
Start date
May 11, 2019
Primary completion
May 31, 2020
Completion
May 31, 2020
Last update
Jan 22, 2021

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 Jan 2021. You cannot join it, but the record below documents what was studied.

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