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The purpose of this study is to evaluate the effect of oral progesterone supplementation in preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy period, and its side effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dydrogesterone | Active Comparator | tocolytic + corticosteroids + Dydrogesterone 10 mg/tablet prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks |
|
| Placebo | Placebo Comparator | tocolytic + corticosteroids + Placebo prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dydrogesterone | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The recurrence of uterine contraction within 48 hours after stop tocolytic | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time from preterm labor pain to delivery | 9 weeks | |
| Gestational age at delivery | 9 weeks | |
| Number of newborn with respiratory distress syndrome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vorapong Phupong, M.D. | Chulalongkorn University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Chulalongkorn University | Bangkok | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 22617615 | Background | 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. | |
| 22996126 |
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| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
|
| 9 weeks |
| side effects | 9 weeks |
| Number of newborn with intraventricular hemorrhage | 9 weeks |
| Number of newborn with necrotizing enterocolitis | 9 weeks |
| Number of newborn with sepsis | 9 weeks |
| Background |
| 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. |
| 23057618 | Background | 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. |
| 22102929 | Background | Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72. |
| 16293412 | Background | 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. |
| 22794306 | Background | 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. |
| 19193503 | Background | 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. |
| 15901258 | Result | 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. |
| 18275573 | Result | 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. |
| Result | 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. |
| 22086108 | Result | 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. |
| 21967664 | Result | 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. |
| 24127952 | Result | 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. |
| D011083 |
| Polycyclic Compounds |