Preterm Labor
Conditions
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.
Interventions
DRUGDydrogesterone
dydrogesterone capsule
DRUGplacebo
placebo capsule
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| latency period | 13 weeks | time from preterm labor to delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| satisfaction | 13 weeks | percentage of good satisfaction |
| Time to the recurrence of uterine contractions | 13 weeks | Time to the recurrence of uterine contractions |
| preterm delivery less than 34 weeks | 10 weeks | percentage of delivery less than 34 weeks |
| compliance | 13 weeks | percentage of complete drug use |
| neonatal complications | 13 weeks | percentage of newborn with RDS, IVH, NEC, death |
| side effects | 13 weeks | percentage of side effects such as headache, nausea/vomiting |
| preterm delivery less than 37 weeks | 13 weeks | percentage of delivery less than 37 weeks |
Countries
Thailand
Outcome results
None listed