Vaginal Progesterone Supplementation in the Management of Preterm Labor

Preterm Labor Clinical Trial

Official title:

Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202836
• Other study ID #: 230/2017
• Status: Completed
• Phase: N/A
• Start date: June 29, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2019
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Drug:
• progesterone
vaginal utrogestan
• Tocolytics
tocolysis for 48 hours
• Steroids
antenatal corticosteroids for 48 hours

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (11)

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

Outcome

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