Adjunctive Vaginal Progesterone in Management of Preterm Labor

Preterm Labor Clinical Trial

Official title:

Adjunctive Vaginal Progesterone (Micronized Progesterone Effervescent Vaginal Tablet) in Management of Preterm Labor: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997563
• Other study ID #: 681/2023
• Status: Recruiting
• Phase: Phase 4
• Start date: August 16, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: August 2023
• Source: Chulalongkorn University
• Contact: Vorapong Phupong, M.D.
• Phone: +66816339296
• Email: vorapong.p[@]chula.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• singleton pregnancy with gestational age 24-33 weeks 6 days

• preterm labor

• received treatment with tocolysis and corticosteroids

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Drug:
• Micronized progesterone
Vaginal micronized progesterone effervescent once daily until delivery

Locations

Country	Name	City	State
Thailand	Vorapong Phupong	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Ne — View Citation

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 avail — View Citation

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, — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	latency period	time from preterm labor to delivery	13 weeks
Secondary	gestational age at delivery	mean gestational age at delivery	13 weeks
Secondary	preterm delivery less than 34 weeks	percentage of preterm delivery less than 34 weeks	10 weeks
Secondary	preterm delivery less than 37 weeks	percentage of preterm delivery less than 37 weeks	13 weeks
Secondary	neonatal complications	percentage of newborn with RDS, IVH, NEC, death	13 weeks
Secondary	side effects	percentage of side effects such as headache, nausea/vomiting	13 weeks
Secondary	compliance	percentage of complete drug use	13 weeks
Secondary	good satisfaction	percentage of good satisfaction	13 weeks
Secondary	good quality of life	percentage of good quality of life	13 weeks
Secondary	Time to the recurrence of uterine contractions	mean time to the recurrence of uterine contractions	13 weeks