Preterm Delivery Prevention in Twins With Progesterone

Pregnancies Clinical Trial

Official title:

Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01927029
• Other study ID #: CAS149
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 19, 2013
• Last updated: August 20, 2013
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: Universidad del Desarrollo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comité de Ética Científico
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 213
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancies

Intervention

Drug:
• Progesterone
Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks.
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Universidad del Desarrollo	Hospital Padre Hurtado, Hospital San Borja-Arriaran

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neonatal mortality	Dead of the newborn, due to preterm delivery	14 months	No
Primary	Preterm delivery <34 weeks	Spontaneous labor under 34 weeks.	14 months	No
Secondary	Preterm delivery <37 weeks	Spontaneous delivery under 37 weeks	14 months	No