search
Back to results

Vaginal Progesterone Supplementation in the Management of Preterm Labor

Primary Purpose

Preterm Labor

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
progesterone
Tocolytics
Steroids
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Labor

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

vaginal progesterone

no medication

Arm Description

Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours

only tocolysis plus corticosteroid for 48 hours

Outcomes

Primary Outcome Measures

Time from preterm labor pain to delivery
time since preterm labor to delivery

Secondary Outcome Measures

gestational age at delivery
gestational age at birth
number of pregnant women deliver before 34 weeks
preterm birth < 34 weeks
number of pregnant women deliver before 37 weeks
preterm birth < 37 weeks
Number of newborn with respiratory distress syndrome
Number of newborn with respiratory distress syndrome
Number of newborn with intraventricular hemorrhage
Number of newborn with intraventricular hemorrhage
Number of newborn with necrotizing enterocolitis
Number of newborn with necrotizing enterocolitis
Number of newborn with sepsis
Number of newborn with sepsis

Full Information

First Posted
June 24, 2017
Last Updated
January 29, 2019
Sponsor
Chulalongkorn University
search

1. Study Identification

Unique Protocol Identification Number
NCT03202836
Brief Title
Vaginal Progesterone Supplementation in the Management of Preterm Labor
Official Title
Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vaginal progesterone
Arm Type
Experimental
Arm Description
Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours
Arm Title
no medication
Arm Type
Other
Arm Description
only tocolysis plus corticosteroid for 48 hours
Intervention Type
Drug
Intervention Name(s)
progesterone
Other Intervention Name(s)
utrogestan
Intervention Description
vaginal utrogestan
Intervention Type
Drug
Intervention Name(s)
Tocolytics
Intervention Description
tocolysis for 48 hours
Intervention Type
Drug
Intervention Name(s)
Steroids
Intervention Description
antenatal corticosteroids for 48 hours
Primary Outcome Measure Information:
Title
Time from preterm labor pain to delivery
Description
time since preterm labor to delivery
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
gestational age at delivery
Description
gestational age at birth
Time Frame
9 weeks
Title
number of pregnant women deliver before 34 weeks
Description
preterm birth < 34 weeks
Time Frame
6 weeks
Title
number of pregnant women deliver before 37 weeks
Description
preterm birth < 37 weeks
Time Frame
9 weeks
Title
Number of newborn with respiratory distress syndrome
Description
Number of newborn with respiratory distress syndrome
Time Frame
9 weeks
Title
Number of newborn with intraventricular hemorrhage
Description
Number of newborn with intraventricular hemorrhage
Time Frame
9 weeks
Title
Number of newborn with necrotizing enterocolitis
Description
Number of newborn with necrotizing enterocolitis
Time Frame
9 weeks
Title
Number of newborn with sepsis
Description
Number of newborn with sepsis
Time Frame
9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vorapong Phupong, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27650091
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. No abstract available.
Results Reference
background
PubMed Identifier
27326415
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. 2016 May;14(5):309-16.
Results Reference
background
PubMed Identifier
27168167
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.
Results Reference
background
PubMed Identifier
26450404
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.
Results Reference
background
PubMed Identifier
21879816
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. No abstract available.
Results Reference
background
PubMed Identifier
21472815
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.
Results Reference
background
PubMed Identifier
12592250
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. doi: 10.1067/mob.2003.41.
Results Reference
background
PubMed Identifier
27028759
Citation
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.
Results Reference
result
PubMed Identifier
25209926
Citation
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.
Results Reference
result
PubMed Identifier
18275573
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.
Results Reference
result
PubMed Identifier
22086108
Citation
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.
Results Reference
result

Learn more about this trial

Vaginal Progesterone Supplementation in the Management of Preterm Labor

We'll reach out to this number within 24 hrs