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Adjunctive Vaginal Progesterone in Management of Preterm Labor

Primary Purpose

Preterm Labor

Status
Recruiting
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Micronized progesterone
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 progesterone contraindication to progesterone contraindication to tocolytic use

Sites / Locations

  • Vorapong PhupongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Micronized progesterone

Control

Arm Description

Outcomes

Primary Outcome Measures

latency period
time from preterm labor to delivery

Secondary Outcome Measures

gestational age at delivery
mean gestational age at delivery
preterm delivery less than 34 weeks
percentage of preterm delivery less than 34 weeks
preterm delivery less than 37 weeks
percentage of preterm 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
good satisfaction
percentage of good satisfaction
good quality of life
percentage of good quality of life
Time to the recurrence of uterine contractions
mean time to the recurrence of uterine contractions

Full Information

First Posted
August 8, 2023
Last Updated
August 28, 2023
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT05997563
Brief Title
Adjunctive Vaginal Progesterone in Management of Preterm Labor
Official Title
Adjunctive Vaginal Progesterone (Micronized Progesterone Effervescent Vaginal Tablet) in Management of Preterm Labor: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

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
No

5. Study Description

Brief Summary
This study evaluates the addition of vaginal micronized progesterone effervescent to standard treatment in the treatment of preterm labor. Half of participants will receive vaginal micronized progesterone effervescent and standard treatment, while the other half will receive only 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
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Micronized progesterone
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Micronized progesterone
Intervention Description
Vaginal micronized progesterone effervescent once daily until delivery
Primary Outcome Measure Information:
Title
latency period
Description
time from preterm labor to delivery
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
gestational age at delivery
Description
mean gestational age at delivery
Time Frame
13 weeks
Title
preterm delivery less than 34 weeks
Description
percentage of preterm delivery less than 34 weeks
Time Frame
10 weeks
Title
preterm delivery less than 37 weeks
Description
percentage of preterm 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
good satisfaction
Description
percentage of good satisfaction
Time Frame
13 weeks
Title
good quality of life
Description
percentage of good quality of life
Time Frame
13 weeks
Title
Time to the recurrence of uterine contractions
Description
mean time to the recurrence of uterine contractions
Time Frame
13 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
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 progesterone contraindication to progesterone contraindication to tocolytic use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vorapong Phupong, M.D.
Phone
+66816339296
Email
vorapong.p@chula.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Jirapat Chanratchakool, M.D.
Phone
+66819322352
Email
sunnjc.jc@gmail.com
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
Vorapong Phupong
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vorapong Phupong, MD
Phone
+66816339296
Email
vorapong.p@chula.ac.th
First Name & Middle Initial & Last Name & Degree
Jirapat Chanratchakool, MD
Email
sunnjc.jc@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27661654
Citation
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Results Reference
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Citation
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Citation
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Citation
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Adjunctive Vaginal Progesterone in Management of Preterm Labor

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