NCT02262481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

October 3, 2014

Last Update Submit

January 26, 2016

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

  • The recurrence of uterine contraction within 48 hours after stop tocolytic

    48 hours

Secondary Outcomes (7)

  • Time from preterm labor pain to delivery

    9 weeks

  • Gestational age at delivery

    9 weeks

  • Number of newborn with respiratory distress syndrome

    9 weeks

  • side effects

    9 weeks

  • Number of newborn with intraventricular hemorrhage

    9 weeks

  • +2 more secondary outcomes

Study Arms (2)

Dydrogesterone

ACTIVE COMPARATOR

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

Drug: dydrogesterone

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

dydrogesteroneDRUG
Also known as: Duphaston
Dydrogesterone
placeboDRUG
Placebo

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (14)

  • 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.

    BACKGROUND

  • 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.

    PMID: 22617615BACKGROUND

  • 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.

    PMID: 22996126BACKGROUND

  • 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.

    PMID: 23057618BACKGROUND

  • Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72.

    PMID: 22102929BACKGROUND

  • 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.

    PMID: 16293412BACKGROUND

  • 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.

    PMID: 22794306BACKGROUND

  • 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.

    PMID: 19193503BACKGROUND

  • 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.

    PMID: 15901258RESULT

  • 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.

    PMID: 18275573RESULT

  • 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.

    RESULT

  • 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.

    PMID: 22086108RESULT

  • 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.

    PMID: 21967664RESULT

  • 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.

    PMID: 24127952RESULT

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Vorapong Phupong, M.D.

    Chulalongkorn University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vorapong

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 13, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

TH(1)