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Oral Dydrogesterone in the Management of Preterm Labor

Primary Purpose

Preterm Labor

Status
Completed
Phase
Phase 4
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 treatment trial for Preterm Labor

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • singleton pregnancy with gestational age 24-33 weeks 6 days
  • preterm labor
  • received treatment with tocolysis and corticosteroids

Exclusion Criteria:

  • conditions that need immediate delivery such as fetal distress, chorioamnionitis
  • have medical complications such as heart disease, seizure
  • fetal anomalies
  • cervical dilatation more than 5 cm
  • 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

dydrogesterone 10 mg by mouth every 8 hours until delivery

placebo by mouth every 8 hours until delivery

Outcomes

Primary Outcome Measures

latency period
time from preterm labor to delivery

Secondary Outcome Measures

preterm delivery less than 34 weeks
percentage of delivery less than 34 weeks
preterm delivery less than 37 weeks
percentage of delivery less than 37 weeks
neonatal complications
percentage of newborn with RDS, IVH, NEC, death
side effects
percentage of side effects such as headache, nausea/vomiting
compliance
percentage of complete drug use
satisfaction
percentage of good satisfaction
Time to the recurrence of uterine contractions
Time to the recurrence of uterine contractions

Full Information

First Posted
April 30, 2019
Last Updated
January 20, 2021
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT03935152
Brief Title
Oral Dydrogesterone in the Management of Preterm Labor
Official Title
Oral Dydrogesterone as Adjunctive Therapy in the Management of Preterm Labor: A Randomized, Double Blinded, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (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 oral dydrogesterone to standard treatment in the treatment of preterm labor. Half of participants will receive oral dydrogesterone and standard treatment, while the other half will receive oral placebo and standard treatment.

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
Phase 4
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
dydrogesterone 10 mg by mouth every 8 hours until delivery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo by mouth every 8 hours until delivery
Intervention Type
Drug
Intervention Name(s)
Dydrogesterone
Intervention Description
dydrogesterone capsule
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo capsule
Primary Outcome Measure Information:
Title
latency period
Description
time from preterm labor to delivery
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
preterm delivery less than 34 weeks
Description
percentage of delivery less than 34 weeks
Time Frame
10 weeks
Title
preterm delivery less than 37 weeks
Description
percentage of delivery less than 37 weeks
Time Frame
13 weeks
Title
neonatal complications
Description
percentage of newborn with RDS, IVH, NEC, death
Time Frame
13 weeks
Title
side effects
Description
percentage of side effects such as headache, nausea/vomiting
Time Frame
13 weeks
Title
compliance
Description
percentage of complete drug use
Time Frame
13 weeks
Title
satisfaction
Description
percentage of good satisfaction
Time Frame
13 weeks
Title
Time to the recurrence of uterine contractions
Description
Time to the recurrence of uterine contractions
Time Frame
13 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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 pregnancy with gestational age 24-33 weeks 6 days preterm labor received treatment with tocolysis and corticosteroids Exclusion Criteria: conditions that need immediate delivery such as fetal distress, chorioamnionitis have medical complications such as heart disease, seizure fetal anomalies cervical dilatation more than 5 cm allergy to dydrogesterone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vorapong Phupong, M.D.
Organizational Affiliation
Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology
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
27661654
Citation
American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi: 10.1097/AOG.0000000000001711.
Results Reference
background
PubMed Identifier
24625129
Citation
Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.
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
29981319
Citation
Yasuda K, Sumi GI, Murata H, Kida N, Kido T, Okada H. The steroid hormone dydrogesterone inhibits myometrial contraction independently of the progesterone/progesterone receptor pathway. Life Sci. 2018 Aug 15;207:508-515. doi: 10.1016/j.lfs.2018.07.004. Epub 2018 Jul 4.
Results Reference
background
PubMed Identifier
19434889
Citation
Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2008 Sep-Oct;61(1-2):171-80. doi: 10.1016/j.maturitas.2008.11.013.
Results Reference
background
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
PubMed Identifier
24807871
Citation
Choudhary M, Suneja A, Vaid NB, Guleria K, Faridi MM. Maintenance tocolysis with oral micronized progesterone for prevention of preterm birth after arrested preterm labor. Int J Gynaecol Obstet. 2014 Jul;126(1):60-3. doi: 10.1016/j.ijgo.2014.01.019. Epub 2014 Apr 3.
Results Reference
result
PubMed Identifier
26856618
Citation
Areeruk W, Phupong V. A randomized, double blinded, placebo controlled trial of oral dydrogesterone supplementation in the management of preterm labor. Sci Rep. 2016 Feb 9;6:20638. doi: 10.1038/srep20638.
Results Reference
result
PubMed Identifier
33509129
Citation
Thongchan S, Phupong V. Oral dydrogesterone as an adjunctive therapy in the management of preterm labor: a randomized, double blinded, placebo-controlled trial. BMC Pregnancy Childbirth. 2021 Jan 28;21(1):90. doi: 10.1186/s12884-021-03562-6.
Results Reference
derived

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Oral Dydrogesterone in the Management of Preterm Labor

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