Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the addition of vaginal progesterone in the management of preterm labor. Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while the other half will receive only tocolysis and corticosteroid.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaginal progesterone | Experimental | Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours |
|
| no medication | Other | only tocolysis plus corticosteroid for 48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| progesterone | Drug | vaginal utrogestan |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from preterm labor pain to delivery | time since preterm labor to delivery | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| gestational age at delivery | gestational age at birth | 9 weeks |
| number of pregnant women deliver before 34 weeks | preterm birth < 34 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vorapong Phupong, MD | Chulalongkorn University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Chulalongkorn University | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27650091 | Background | O'Brien JM. Vaginal progesterone prophylaxis for preterm birth. Lancet. 2016 Sep 17;388(10050):1159-60. doi: 10.1016/S0140-6736(16)31614-2. Epub 2016 Sep 16. No abstract available. | |
| 27326415 | Background | Azargoon A, Ghorbani R, Aslebahar F. Vaginal progesterone on the prevention of preterm birth and neonatal complications in high risk women: A randomized placebo-controlled double-blind study. Int J Reprod Biomed. 2016 May;14(5):309-16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D011374 | Progesterone |
| C000624167 | Utrogestan |
| D015149 | Tocolytic Agents |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tocolytics | Drug | tocolysis for 48 hours |
|
| Steroids | Drug | antenatal corticosteroids for 48 hours |
|
| 6 weeks |
| number of pregnant women deliver before 37 weeks | preterm birth < 37 weeks | 9 weeks |
| Number of newborn with respiratory distress syndrome | Number of newborn with respiratory distress syndrome | 9 weeks |
| Number of newborn with intraventricular hemorrhage | Number of newborn with intraventricular hemorrhage | 9 weeks |
| Number of newborn with necrotizing enterocolitis | Number of newborn with necrotizing enterocolitis | 9 weeks |
| Number of newborn with sepsis | Number of newborn with sepsis | 9 weeks |
| 27168167 | Background | Elimian A, Smith K, Williams M, Knudtson E, Goodman JR, Escobedo MB. A randomized controlled trial of intramuscular versus vaginal progesterone for the prevention of recurrent preterm birth. Int J Gynaecol Obstet. 2016 Aug;134(2):169-72. doi: 10.1016/j.ijgo.2016.01.010. Epub 2016 Apr 18. |
| 26450404 | Background | Conde-Agudelo A, Romero R. Vaginal progesterone to prevent preterm birth in pregnant women with a sonographic short cervix: clinical and public health implications. Am J Obstet Gynecol. 2016 Feb;214(2):235-242. doi: 10.1016/j.ajog.2015.09.102. Epub 2015 Oct 9. |
| 21879816 | Background | Romero R. Vaginal progesterone to reduce the rate of preterm birth and neonatal morbidity: a solution at last. Womens Health (Lond). 2011 Sep;7(5):501-4. doi: 10.2217/whe.11.60. No abstract available. |
| 21472815 | Background | Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15. |
| 12592250 | Background | da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2003 Feb;188(2):419-24. doi: 10.1067/mob.2003.41. |
| 27028759 | Result | Palacio M, Cobo T, Antolin E, Ramirez M, Cabrera F, Mozo de Rosales F, Bartha JL, Juan M, Marti A, Oros D, Rodriguez A, Scazzocchio E, Olivares JM, Varea S, Rios J, Gratacos E; PROMISE Collaborative Group. Vaginal progesterone as maintenance treatment after an episode of preterm labour (PROMISE) study: a multicentre, double-blind, randomised, placebo-controlled trial. BJOG. 2016 Nov;123(12):1990-1999. doi: 10.1111/1471-0528.13956. Epub 2016 Mar 30. |
| 25209926 | Result | Martinez de Tejada B, Karolinski A, Ocampo MC, Laterra C, Hosli I, Fernandez D, Surbek D, Huespe M, Drack G, Bunader A, Rouillier S, Lopez de Degani G, Seidenstein E, Prentl E, Anton J, Krahenmann F, Nowacki D, Poncelas M, Nassif JC, Papera R, Tuma C, Espoile R, Tiberio O, Breccia G, Messina A, Peker B, Schinner E, Mol BW, Kanterewicz L, Wainer V, Boulvain M, Othenin-Girard V, Bertolino MV, Irion O; 4P trial group. Prevention of preterm delivery with vaginal progesterone in women with preterm labour (4P): randomised double-blind placebo-controlled trial. BJOG. 2015 Jan;122(1):80-91. doi: 10.1111/1471-0528.13061. Epub 2014 Sep 11. |
| 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. |
| 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. |
| D011083 |
| Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |