NCT03935152CompletedPhase 4
Oral Dydrogesterone as Adjunctive Therapy in the Management of Preterm Labor: A Randomized, Double Blinded, Placebo-controlled Trial
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Chulalongkorn University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- latency period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Dydrogesterone
Active Comparator
dydrogesterone 10 mg by mouth every 8 hours until delivery
Intervention: Dydrogesterone (Drug)
Placebo
Placebo Comparator
placebo by mouth every 8 hours until delivery
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
latency period
Time Frame: 13 weeks
time from preterm labor to delivery
Secondary Outcomes
- compliance(13 weeks)
- preterm delivery less than 34 weeks(10 weeks)
- Time to the recurrence of uterine contractions(13 weeks)
- neonatal complications(13 weeks)
- satisfaction(13 weeks)
- preterm delivery less than 37 weeks(13 weeks)
- side effects(13 weeks)
Investigators
Vorapong Phupong
Professor
Chulalongkorn University
Study Sites (1)
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