Preterm Labor Clinical Trial
Official title:
Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial
NCT number | NCT03202836 |
Other study ID # | 230/2017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 29, 2017 |
Est. completion date | July 31, 2018 |
Verified date | January 2019 |
Source | Chulalongkorn University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine, Chulalongkorn University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Chulalongkorn University |
Thailand,
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. — View Citation
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 (Yazd). 2016 May;14(5):309-16. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Martinez de Tejada B, Karolinski A, Ocampo MC, Laterra C, Hösli I, Fernández D, Surbek D, Huespe M, Drack G, Bunader A, Rouillier S, López de Degani G, Seidenstein E, Prentl E, Antón J, Krähenmann F, Nowacki D, Poncelas M, Nassif JC, Papera R, Tuma C, Esp — View Citation
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. — View Citation
Palacio M, Cobo T, Antolín E, Ramirez M, Cabrera F, Mozo de Rosales F, Bartha JL, Juan M, Martí A, Oros D, Rodríguez À, Scazzocchio E, Olivares JM, Varea S, Ríos J, Gratacós E; PROMISE Collaborative Group. Vaginal progesterone as maintenance treatment aft — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time from preterm labor pain to delivery | time since preterm labor to delivery | 9 weeks | |
Secondary | gestational age at delivery | gestational age at birth | 9 weeks | |
Secondary | number of pregnant women deliver before 34 weeks | preterm birth < 34 weeks | 6 weeks | |
Secondary | number of pregnant women deliver before 37 weeks | preterm birth < 37 weeks | 9 weeks | |
Secondary | Number of newborn with respiratory distress syndrome | Number of newborn with respiratory distress syndrome | 9 weeks | |
Secondary | Number of newborn with intraventricular hemorrhage | Number of newborn with intraventricular hemorrhage | 9 weeks | |
Secondary | Number of newborn with necrotizing enterocolitis | Number of newborn with necrotizing enterocolitis | 9 weeks | |
Secondary | Number of newborn with sepsis | Number of newborn with sepsis | 9 weeks |
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