Preterm Labor
Conditions
Brief summary
This study evaluates the addition of vaginal progesterone in the management of preterm labor. Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while the other half will receive only tocolysis and corticosteroid.
Interventions
DRUGprogesterone
vaginal utrogestan
DRUGTocolytics
tocolysis for 48 hours
DRUGSteroids
antenatal corticosteroids for 48 hours
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 pregnant women with preterm labor, gestational age 24-34 weeks
Exclusion criteria
* have indicated preterm birth * allergy to progesterone * fetal anomalies * cervical dilate \> 5 cm. * have medical disease * have obstetric complication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from preterm labor pain to delivery | 9 weeks | time since preterm labor to delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of pregnant women deliver before 34 weeks | 6 weeks | preterm birth \< 34 weeks |
| number of pregnant women deliver before 37 weeks | 9 weeks | preterm birth \< 37 weeks |
| Number of newborn with respiratory distress syndrome | 9 weeks | Number of newborn with respiratory distress syndrome |
| gestational age at delivery | 9 weeks | gestational age at birth |
| Number of newborn with necrotizing enterocolitis | 9 weeks | Number of newborn with necrotizing enterocolitis |
| Number of newborn with sepsis | 9 weeks | Number of newborn with sepsis |
| Number of newborn with intraventricular hemorrhage | 9 weeks | Number of newborn with intraventricular hemorrhage |
Countries
Thailand
Outcome results
None listed