<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02262481</url>
  </required_header>
  <id_info>
    <org_study_id>RA57/104</org_study_id>
    <nct_id>NCT02262481</nct_id>
  </id_info>
  <brief_title>Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor</brief_title>
  <official_title>A Randomized, Double Blinded, Placebo Controlled Trial of Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of oral progesterone supplementation in&#xD;
      preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy&#xD;
      period, and its side effect.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The recurrence of uterine contraction within 48 hours after stop tocolytic</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from preterm labor pain to delivery</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational age at delivery</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of newborn with respiratory distress syndrome</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of newborn with intraventricular hemorrhage</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of newborn with necrotizing enterocolitis</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of newborn with sepsis</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Preterm Labor</condition>
  <arm_group>
    <arm_group_label>Dydrogesterone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>tocolytic + corticosteroids + Dydrogesterone 10 mg/tablet prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>tocolytic + corticosteroids + Placebo prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dydrogesterone</intervention_name>
    <arm_group_label>Dydrogesterone</arm_group_label>
    <other_name>Duphaston</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Preterm labor&#xD;
&#xD;
          -  GA24-34wk&#xD;
&#xD;
          -  Intact membranes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Maternal/fetal condition requiring immediate delivery ex. Chorioamnionitis, fetal&#xD;
             distress&#xD;
&#xD;
          -  Placenta previa&#xD;
&#xD;
          -  medical and obstetric complications&#xD;
&#xD;
          -  allergy to dydrogesterone&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vorapong Phupong, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Chulalongkorn University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, Chulalongkorn University</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <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.</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22617615</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22996126</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23057618</PMID>
  </reference>
  <reference>
    <citation>Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72.</citation>
    <PMID>22102929</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16293412</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22794306</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19193503</PMID>
  </reference>
  <results_reference>
    <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.</citation>
    <PMID>15901258</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>18275573</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>22086108</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>21967664</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>24127952</PMID>
  </results_reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>January 26, 2016</last_update_submitted>
  <last_update_submitted_qc>January 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Vorapong Phupong</investigator_full_name>
    <investigator_title>Vorapong</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Obstetric Labor, Premature</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dydrogesterone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02262481
org study id: RA57/104
nct id: NCT02262481
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The recurrence of uterine contraction within 48 hours after stop tocolytic
time frame: 48 hours
measure: Time from preterm labor pain to delivery
time frame: 9 weeks
measure: Gestational age at delivery
time frame: 9 weeks
measure: Number of newborn with respiratory distress syndrome
time frame: 9 weeks
measure: side effects
time frame: 9 weeks
measure: Number of newborn with intraventricular hemorrhage
time frame: 9 weeks
measure: Number of newborn with necrotizing enterocolitis
time frame: 9 weeks
measure: Number of newborn with sepsis
time frame: 9 weeks
arm group label: Dydrogesterone
arm group type: Active Comparator
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 group label: Placebo
arm group type: Placebo Comparator
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: dydrogesterone
arm group label: Dydrogesterone
other name: Duphaston
intervention type: Drug
intervention name: placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vorapong Phupong, M.D.
role: Study Director
affiliation: Chulalongkorn University
facility: 
country: Thailand
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.
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.
PMID: 22617615
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.
PMID: 22996126
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.
PMID: 23057618
citation: Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72.
PMID: 22102929
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.
PMID: 16293412
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.
PMID: 22794306
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.
PMID: 19193503
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.
PMID: 15901258
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.
PMID: 18275573
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.
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.
PMID: 22086108
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.
PMID: 21967664
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.
PMID: 24127952
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Vorapong Phupong
investigator title: Vorapong
mesh term: Premature Birth
mesh term: Obstetric Labor, Premature
mesh term: Dydrogesterone