Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial
| Registry | NCT03202836 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
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| Enrollment | 90 (Actual) |
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| Sponsor | Chulalongkorn University (Other) |
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| Conditions | Preterm Labor |
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| Interventions | progesterone, Tocolytics, Steroids (Drug) |
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| Dates | start 2017-06-29, primary completion 2018-07-30, completion 2018-07-31, first posted 2017-06-29, last updated 2019-01-31 |
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| Locations | 1 site in Thailand |
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Related Papers Related Patents Related Grants Related Experts
All trials for Preterm Labor All trials of progesterone All trials of Tocolytics
-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| vaginal progesterone | Experimental | Drug: progesterone; Drug: Tocolytics; Drug: Steroids | 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 | Drug: Tocolytics; Drug: Steroids | only tocolysis plus corticosteroid for 48 hours |
- progesterone (Drug), also known as utrogestan: vaginal utrogestan
- Tocolytics (Drug): tocolysis for 48 hours
- Steroids (Drug): antenatal corticosteroids for 48 hours
+Outcome measures
Primary outcomes
- Time from preterm labor pain to delivery [9 weeks]: time since preterm labor to delivery
Secondary outcomes
- gestational age at delivery [9 weeks]: gestational age at birth
- number of pregnant women deliver before 34 weeks [6 weeks]: preterm birth < 34 weeks
- number of pregnant women deliver before 37 weeks [9 weeks]: preterm birth < 37 weeks
- Number of newborn with respiratory distress syndrome [9 weeks]: Number of newborn with respiratory distress syndrome
- Number of newborn with intraventricular hemorrhage [9 weeks]: Number of newborn with intraventricular hemorrhage
- Number of newborn with necrotizing enterocolitis [9 weeks]: Number of newborn with necrotizing enterocolitis
- Number of newborn with sepsis [9 weeks]: Number of newborn with sepsis
+Eligibility
Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria:
* singleton pregnant women with preterm labor, gestational age 24-34 weeks
Exclusion Criteria:
* have indicated preterm birth
* allergy to progesterone
* fetal anomalies
* cervical dilate > 5 cm.
* have medical disease
* have obstetric complication
+Locations (1)
| Facility | City | Country | Status |
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| Faculty of Medicine, Chulalongkorn University | Bangkok | Thailand | |
+Publications
- 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. PMID 27650091
- 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. PMID 27326415
- 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. PMID 27168167
- 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. PMID 26450404
- 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. PMID 21879816
- 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. PMID 21472815
- 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. PMID 12592250
- Results publication: 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. PMID 27028759
- Results publication: 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. PMID 25209926
- Results publication: 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. PMID 18275573
- Results publication: 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. PMID 22086108
+Investigators