CClinicalTrials.gg
Sign In
RecruitingNCT05997563Updated Aug 30, 2023

Adjunctive Vaginal Progesterone in Management of Preterm Labor

A Phase 4 interventional study of Micronized progesterone in Preterm Labor, sponsored by Chulalongkorn University. Recruiting 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 Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 1 month later.
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 vaginal micronized progesterone effervescent to standard treatment in the treatment of preterm labor. Half of participants will receive vaginal micronized progesterone effervescent and standard treatment, while the other half will receive only standard treatment.

02

Conditions studied

  • Preterm Labor
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 48 is below the median of 84 across 1,689 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 progesterone
  • contraindication to progesterone
  • contraindication to tocolytic use
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Micronized progesterone

    Drug: Micronized progesterone

  • No intervention
    Control

Interventions

  • DrugMicronized progesterone

    Vaginal micronized progesterone effervescent once daily until delivery

06

What researchers measure

Primary outcomes

  1. latency period

    time from preterm labor to delivery

    Time frame: 13 weeks

Secondary outcomes

  1. gestational age at delivery

    mean gestational age at delivery

    Time frame: 13 weeks

  2. preterm delivery less than 34 weeks

    percentage of preterm delivery less than 34 weeks

    Time frame: 10 weeks

  3. preterm delivery less than 37 weeks

    percentage of preterm delivery less than 37 weeks

    Time frame: 13 weeks

  4. neonatal complications

    percentage of newborn with RDS, IVH, NEC, death

    Time frame: 13 weeks

  5. side effects

    percentage of side effects such as headache, nausea/vomiting

    Time frame: 13 weeks

  6. compliance

    percentage of complete drug use

    Time frame: 13 weeks

  7. good satisfaction

    percentage of good satisfaction

    Time frame: 13 weeks

  8. good quality of life

    percentage of good quality of life

    Time frame: 13 weeks

  9. Time to the recurrence of uterine contractions

    mean time to the recurrence of uterine contractions

    Time frame: 13 weeks

07

Study locations

1 of 1 sites recruiting
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 ↗
  • Coomarasamy A, Williams H, Truchanowicz E, Seed PT, Small R, Quenby S, Gupta P, Dawood F, Koot YE, Atik RB, Bloemenkamp KW, Brady R, Briley A, Cavallaro R, Cheong YC, Chu J, Eapen A, Essex H, Ewies A, Hoek A, Kaaijk EM, Koks CA, Li TC, MacLean M, Mol BW, Moore J, Parrott S, Ross JA, Sharpe L, Stewart J, Trepel D, Vaithilingam N, Farquharson RG, Kilby MD, Khalaf Y, Goddijn M, Regan L, Rai R. PROMISE: first-trimester progesterone therapy in women with a history of unexplained recurrent miscarriages - a randomised, double-blind, placebo-controlled, international multicentre trial and economic evaluation. Health Technol Assess. 2016 May;20(41):1-92. doi: 10.3310/hta20410. PubMed 27225013 ↗
  • Facchinetti F, Vergani P, Di Tommaso M, Marozio L, Acaia B, Vicini R, Pignatti L, Locatelli A, Spitaleri M, Benedetto C, Zaina B, D'Amico R. Progestogens for Maintenance Tocolysis in Women With a Short Cervix: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):64-70. doi: 10.1097/AOG.0000000000002065. PubMed 28594783 ↗
  • Coomarasamy A, Devall AJ, Cheed V, Harb H, Middleton LJ, Gallos ID, Williams H, Eapen AK, Roberts T, Ogwulu CC, Goranitis I, Daniels JP, Ahmed A, Bender-Atik R, Bhatia K, Bottomley C, Brewin J, Choudhary M, Crosfill F, Deb S, Duncan WC, Ewer A, Hinshaw K, Holland T, Izzat F, Johns J, Kriedt K, Lumsden MA, Manda P, Norman JE, Nunes N, Overton CE, Quenby S, Rao S, Ross J, Shahid A, Underwood M, Vaithilingam N, Watkins L, Wykes C, Horne A, Jurkovic D. A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy. N Engl J Med. 2019 May 9;380(19):1815-1824. doi: 10.1056/NEJMoa1813730. PubMed 31067371 ↗
  • Piette PCM. The pharmacodynamics and safety of progesterone. Best Pract Res Clin Obstet Gynaecol. 2020 Nov;69:13-29. doi: 10.1016/j.bpobgyn.2020.06.002. Epub 2020 Jun 25. PubMed 32739288 ↗
  • ACOG Practice Bulletin No.142: Cerclage for the management of cervical insufficiency. Obstet Gynecol. 2014 Feb;123(2 Pt 1):372-379. doi: 10.1097/01.AOG.0000443276.68274.cc. PubMed 24451674 ↗
  • Cicinelli E, De Ziegler D, Morgese S, Bulletti C, Luisi D, Schonauer LM. "First uterine pass effect" is observed when estradiol is placed in the upper but not lower third of the vagina. Fertil Steril. 2004 May;81(5):1414-6. doi: 10.1016/j.fertnstert.2003.12.016. PubMed 15136116 ↗
  • Simunic V, Tomic V, Tomic J, Nizic D. Comparative study of the efficacy and tolerability of two vaginal progesterone formulations, Crinone 8% gel and Utrogestan capsules, used for luteal support. Fertil Steril. 2007 Jan;87(1):83-7. doi: 10.1016/j.fertnstert.2006.05.067. Epub 2006 Nov 1. Erratum In: Fertil Steril. 2007 Jul;88(1):254. PubMed 17081536 ↗
  • Shiba R, Kinutani M, Okano S, Kawano R, Kikkawa Y. Efficacy of four vaginal progesterones for luteal phase support in frozen-thawed embryo transfer cycles: A randomized clinical trial. Reprod Med Biol. 2019 Sep 16;19(1):42-49. doi: 10.1002/rmb2.12300. eCollection 2020 Jan. PubMed 31956284 ↗
  • Schumacher M, Liere P, Ghoumari A. Progesterone and fetal-neonatal neuroprotection. Best Pract Res Clin Obstet Gynaecol. 2020 Nov;69:50-61. doi: 10.1016/j.bpobgyn.2020.09.001. Epub 2020 Sep 8. PubMed 33039311 ↗
  • Norman JE, Marlow N, Messow CM, Shennan A, Bennett PR, Thornton S, Robson SC, McConnachie A, Petrou S, Sebire NJ, Lavender T, Whyte S, Norrie J; OPPTIMUM study group. Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial. Lancet. 2016 May 21;387(10033):2106-2116. doi: 10.1016/S0140-6736(16)00350-0. Epub 2016 Feb 24. Erratum In: Lancet. 2019 Jan 19;393(10168):228. doi: 10.1016/S0140-6736(18)32625-4. Lancet. 2019 Apr 20;393(10181):1596. doi: 10.1016/S0140-6736(19)30860-8. PubMed 26921136 ↗
  • Martinez de Tejada B, Karolinski A. Vaginal progesterone for maintenance tocolysis: a systematic review and metaanalysis of randomized trials. Am J Obstet Gynecol. 2015 Sep;213(3):438-9. doi: 10.1016/j.ajog.2015.05.037. Epub 2015 May 21. No abstract available. PubMed 26003056 ↗
  • Ashoush S, El-Kady O, Al-Hawwary G, Othman A. The value of oral micronized progesterone in the prevention of recurrent spontaneous preterm birth: a randomized controlled trial. Acta Obstet Gynecol Scand. 2017 Dec;96(12):1460-1466. doi: 10.1111/aogs.13236. Epub 2017 Oct 19. PubMed 28949010 ↗
  • Hyett J, Asadi N, Zare Khafri M, Vafaei H, Kasraeian M, Salehi A, Saadati N, Bazrafshan K. The use of vaginal progesterone as a maintenance therapy in women with arrested preterm labor: a double-blind placebo-randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Mar;35(6):1134-1140. doi: 10.1080/14767058.2020.1743662. Epub 2020 Mar 26. PubMed 32216490 ↗
  • Palacio M, Ronzoni S, Sanchez-Ramos L, Murphy KE. Progestogens as Maintenance Treatment in Arrested Preterm Labor: A Systematic Review and Meta-analysis. Obstet Gynecol. 2016 Nov;128(5):989-1000. doi: 10.1097/AOG.0000000000001676. PubMed 27741193 ↗

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
NCT05997563
Lead sponsor
Chulalongkorn University
Responsible party
Vorapong Phupong (Professor Vorapong Phupong, Chulalongkorn University) — Principal investigator
First posted
Aug 18, 2023
Start date
Aug 16, 2023
Primary completion
Aug 31, 2025 (estimated)
Completion
Oct 31, 2025 (estimated)
Last update
Aug 30, 2023

Study contacts

Vorapong Phupong, M.D.
Contact
vorapong.p@chula.ac.th
+66816339296
Jirapat Chanratchakool, M.D.
Contact
sunnjc.jc@gmail.com
+66819322352
Vorapong Phupong, M.D.
study director · Chulalongkorn University

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Premature Birth→

Other studies from this sponsor

Chulalongkorn University

Start the discussion