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Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

Primary Purpose

Preterm Labor

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

About this trial

This is an interventional prevention trial for Preterm Labor

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Singleton pregnancy
  • Preterm labor
  • GA24-34wk
  • Intact membranes

Exclusion Criteria:

  • Maternal/fetal condition requiring immediate delivery ex. Chorioamnionitis, fetal distress
  • Placenta previa
  • medical and obstetric complications
  • allergy to dydrogesterone

Sites / Locations

  • Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dydrogesterone

Placebo

Arm Description

tocolytic + corticosteroids + Dydrogesterone 10 mg/tablet prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks

tocolytic + corticosteroids + Placebo prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks

Outcomes

Primary Outcome Measures

The recurrence of uterine contraction within 48 hours after stop tocolytic

Secondary Outcome Measures

Time from preterm labor pain to delivery
Gestational age at delivery
Number of newborn with respiratory distress syndrome
side effects
Number of newborn with intraventricular hemorrhage
Number of newborn with necrotizing enterocolitis
Number of newborn with sepsis

Full Information

First Posted
October 3, 2014
Last Updated
January 26, 2016
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT02262481
Brief Title
Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor
Official Title
A Randomized, Double Blinded, Placebo Controlled Trial of Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of oral progesterone supplementation in preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy period, and its side effect.

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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dydrogesterone
Arm Type
Active Comparator
Arm Description
tocolytic + corticosteroids + Dydrogesterone 10 mg/tablet prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
tocolytic + corticosteroids + Placebo prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks
Intervention Type
Drug
Intervention Name(s)
dydrogesterone
Other Intervention Name(s)
Duphaston
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
The recurrence of uterine contraction within 48 hours after stop tocolytic
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Time from preterm labor pain to delivery
Time Frame
9 weeks
Title
Gestational age at delivery
Time Frame
9 weeks
Title
Number of newborn with respiratory distress syndrome
Time Frame
9 weeks
Title
side effects
Time Frame
9 weeks
Title
Number of newborn with intraventricular hemorrhage
Time Frame
9 weeks
Title
Number of newborn with necrotizing enterocolitis
Time Frame
9 weeks
Title
Number of newborn with sepsis
Time Frame
9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Singleton pregnancy Preterm labor GA24-34wk Intact membranes Exclusion Criteria: Maternal/fetal condition requiring immediate delivery ex. Chorioamnionitis, fetal distress Placenta previa medical and obstetric complications allergy to dydrogesterone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vorapong Phupong, M.D.
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

Citations:
Citation
Preterm birth. In: Cunningham FG, Leveno KJ, Bloom SL, Hault JC, Rouse DJ, Spong CY, editors. Williams Obstetrics. 23rd ed. McGraw-Hill; 2010. p. 804-831.
Results Reference
background
PubMed Identifier
22617615
Citation
American College of Obstetricians and Gynecologists; Committee on Practice Bulletins-Obstetrics. ACOG practice bulletin no. 127: Management of preterm labor. Obstet Gynecol. 2012 Jun;119(6):1308-17. doi: 10.1097/AOG.0b013e31825af2f0.
Results Reference
background
PubMed Identifier
22996126
Citation
Committee on Practice Bulletins-Obstetrics, The American College of Obstetricians and Gynecologists. Practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012 Oct;120(4):964-73. doi: 10.1097/AOG.0b013e3182723b1b. No abstract available.
Results Reference
background
PubMed Identifier
23057618
Citation
Di Renzo GC, Giardina I, Clerici G, Mattei A, Alajmi AH, Gerli S. The role of progesterone in maternal and fetal medicine. Gynecol Endocrinol. 2012 Nov;28(11):925-32. doi: 10.3109/09513590.2012.730576.
Results Reference
background
PubMed Identifier
22102929
Citation
Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72.
Results Reference
background
PubMed Identifier
16293412
Citation
Omar MH, Mashita MK, Lim PS, Jamil MA. Dydrogesterone in threatened abortion: pregnancy outcome. J Steroid Biochem Mol Biol. 2005 Dec;97(5):421-5. doi: 10.1016/j.jsbmb.2005.08.013. Epub 2005 Nov 15.
Results Reference
background
PubMed Identifier
22794306
Citation
Carp H. A systematic review of dydrogesterone for the treatment of threatened miscarriage. Gynecol Endocrinol. 2012 Dec;28(12):983-90. doi: 10.3109/09513590.2012.702875. Epub 2012 Jul 16.
Results Reference
background
PubMed Identifier
19193503
Citation
Queisser-Luft A. Dydrogesterone use during pregnancy: overview of birth defects reported since 1977. Early Hum Dev. 2009 Jun;85(6):375-7. doi: 10.1016/j.earlhumdev.2008.12.016. Epub 2009 Feb 3.
Results Reference
background
PubMed Identifier
15901258
Citation
Dodd JM, Crowther CA, Cincotta R, Flenady V, Robinson JS. Progesterone supplementation for preventing preterm birth: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2005 Jun;84(6):526-33. doi: 10.1111/j.0001-6349.2005.00835.x.
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
Citation
Sharami SH, Zahiri Z, Shakiba M, Milani F. Maintenance therapy by vaginal progesterone after threatened idiopathic preterm labor: a randomized placebo-controlled double-blind trial. Int J Fertil Steril 2010;4:45-50.
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
PubMed Identifier
21967664
Citation
Bomba-Opon DA, Kosinska-Kaczynska K, Kosinski P, Wegrzyn P, Kaczynski B, Wielgos M. Vaginal progesterone after tocolytic therapy in threatened preterm labor. J Matern Fetal Neonatal Med. 2012 Jul;25(7):1156-9. doi: 10.3109/14767058.2011.629014. Epub 2012 Apr 3.
Results Reference
result
PubMed Identifier
24127952
Citation
Areia A, Fonseca E, Moura P. Progesterone use after successful treatment of threatened pre-term delivery. J Obstet Gynaecol. 2013 Oct;33(7):678-81. doi: 10.3109/01443615.2013.820266.
Results Reference
result

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Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

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