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Preterm Delivery Prevention in Twins With Progesterone

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ClinicalTrials.gov Identifier: NCT01927029
Recruitment Status : Unknown
Verified August 2013 by Masami Yamamoto, Clinica Alemana de Santiago.
Recruitment status was:  Active, not recruiting
First Posted : August 21, 2013
Last Update Posted : August 21, 2013
Sponsor:
Collaborators:
Hospital Padre Hurtado
Hospital San Borja-Arriaran
Information provided by (Responsible Party):
Masami Yamamoto, Clinica Alemana de Santiago

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%.

Condition or disease Intervention/treatment Phase
Pregnancies Drug: Progesterone Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.
Study Start Date : August 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Progesterone
Daily administration of vaginal progesterone, 180mg, in gel, from 18 weeks to 34 weeks.
Drug: Progesterone
Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks.
Other Name: Progendo gel

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



Primary Outcome Measures :
  1. Preterm delivery <34 weeks [ Time Frame: 14 months ]
    Spontaneous labor under 34 weeks.


Secondary Outcome Measures :
  1. Preterm delivery <37 weeks [ Time Frame: 14 months ]
    Spontaneous delivery under 37 weeks


Other Outcome Measures:
  1. Neonatal mortality [ Time Frame: 14 months ]
    Dead of the newborn, due to preterm delivery



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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Masami Yamamoto, MD, Clinica Alemana de Santiago
ClinicalTrials.gov Identifier: NCT01927029     History of Changes
Other Study ID Numbers: CAS149
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by Masami Yamamoto, Clinica Alemana de Santiago:
twin pregnancy
progesterone
preterm delivery
>14 years
Abscense of cerclage,
TTTS, hemorrage,
history of thrombosis.
cervix >15mm

Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs