Preterm Delivery Prevention in Twins With Progesterone

Universidad del Desarrollo

Status and phase: Unknown; Phase 4

Conditions: Pregnancies

Treatments: Drug: Placebo; Drug: Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT01927029

CAS149

Details and patient eligibility

About

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%.

Enrollment: 213 patients

Sex: Female

Ages: 14 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

213 participants in 2 patient groups, including a placebo group

Progesterone

Experimental group

Description:

Daily administration of vaginal progesterone, 180mg, in gel, from 18 weeks to 34 weeks.

Treatment:

Drug: Progesterone

Placebo

Placebo Comparator group

Description:

Placebo Gel, for daily use from 18 weeks to 34 weeks.

Treatment:

Drug: Placebo