Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor
NCT ID: NCT02262481
Last Updated: 2016-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2014-08-31
2015-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vaginal Progesterone Supplementation in the Management of Preterm Labor
NCT03202836
Efficacy of Oral Progesterone and Vaginal Progesterone After Tocolytic Therapy in Threatened Preterm Labor
NCT02989519
Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor
NCT01840228
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
NCT00422526
Oral Progesterone for Prevention of Preterm Birth
NCT01180296
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dydrogesterone
tocolytic + corticosteroids + Dydrogesterone 10 mg/tablet prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks
dydrogesterone
Placebo
tocolytic + corticosteroids + Placebo prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks
placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dydrogesterone
placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Preterm labor
* GA24-34wk
* Intact membranes
Exclusion Criteria
* Placenta previa
* medical and obstetric complications
* allergy to dydrogesterone
15 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chulalongkorn University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vorapong Phupong
Vorapong
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vorapong Phupong, M.D.
Role: STUDY_DIRECTOR
Chulalongkorn University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, Thailand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Preterm birth. In: Cunningham FG, Leveno KJ, Bloom SL, Hault JC, Rouse DJ, Spong CY, editors. Williams Obstetrics. 23rd ed. McGraw-Hill; 2010. p. 804-831.
American College of Obstetricians and Gynecologists; Committee on Practice Bulletins-Obstetrics. ACOG practice bulletin no. 127: Management of preterm labor. Obstet Gynecol. 2012 Jun;119(6):1308-17. doi: 10.1097/AOG.0b013e31825af2f0.
Committee on Practice Bulletins-Obstetrics, The American College of Obstetricians and Gynecologists. Practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012 Oct;120(4):964-73. doi: 10.1097/AOG.0b013e3182723b1b. No abstract available.
Di Renzo GC, Giardina I, Clerici G, Mattei A, Alajmi AH, Gerli S. The role of progesterone in maternal and fetal medicine. Gynecol Endocrinol. 2012 Nov;28(11):925-32. doi: 10.3109/09513590.2012.730576.
Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72.
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.
Carp H. A systematic review of dydrogesterone for the treatment of threatened miscarriage. Gynecol Endocrinol. 2012 Dec;28(12):983-90. doi: 10.3109/09513590.2012.702875. Epub 2012 Jul 16.
Queisser-Luft A. Dydrogesterone use during pregnancy: overview of birth defects reported since 1977. Early Hum Dev. 2009 Jun;85(6):375-7. doi: 10.1016/j.earlhumdev.2008.12.016. Epub 2009 Feb 3.
Dodd JM, Crowther CA, Cincotta R, Flenady V, Robinson JS. Progesterone supplementation for preventing preterm birth: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2005 Jun;84(6):526-33. doi: 10.1111/j.0001-6349.2005.00835.x.
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.
Sharami SH, Zahiri Z, Shakiba M, Milani F. Maintenance therapy by vaginal progesterone after threatened idiopathic preterm labor: a randomized placebo-controlled double-blind trial. Int J Fertil Steril 2010;4:45-50.
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.
Bomba-Opon DA, Kosinska-Kaczynska K, Kosinski P, Wegrzyn P, Kaczynski B, Wielgos M. Vaginal progesterone after tocolytic therapy in threatened preterm labor. J Matern Fetal Neonatal Med. 2012 Jul;25(7):1156-9. doi: 10.3109/14767058.2011.629014. Epub 2012 Apr 3.
Areia A, Fonseca E, Moura P. Progesterone use after successful treatment of threatened pre-term delivery. J Obstet Gynaecol. 2013 Oct;33(7):678-81. doi: 10.3109/01443615.2013.820266.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RA57/104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.