Pregnancies
Conditions
Keywords
twin pregnancy, progesterone, preterm delivery, >14 years, Abscense of cerclage,, TTTS, hemorrage,, history of thrombosis., cervix >15mm
Brief summary
Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit of progesterone in this population. In contrast, singleton pregnancies are treated with this hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each group are needed to demonstrate a reduction of preterm delivery \<34weeks from 13% to 7%.
Interventions
DRUGProgesterone
Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks.
DRUGPlacebo
Sponsors
Hospital Padre Hurtado
Hospital San Borja-Arriaran
Universidad del Desarrollo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Monochorionic or Dichorionic twin pregnancies * 18 weeks to 24 weeks at inclusion.
Exclusion criteria
* Cerclage before inclusion * Contractions, rupture of the membranes, cervix dilation, * Short cervix (15mm or 20mm if there is history of preterm delivery * Monoamniotic twins, Major malformation, Selective IUGR, TRAP, TTTS. * Younger than 14 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preterm delivery <34 weeks | 14 months | Spontaneous labor under 34 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preterm delivery <37 weeks | 14 months | Spontaneous delivery under 37 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neonatal mortality | 14 months | Dead of the newborn, due to preterm delivery |
Outcome results
None listed