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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2019
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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 allClick 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
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