Preterm Delivery Prevention in Twins With Progesterone

August 20, 2013 updated by: Masami Yamamoto, Universidad del Desarrollo

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

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%.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • Progendo gel
PLACEBO_COMPARATOR: Placebo
Placebo Gel, for daily use from 18 weeks to 34 weeks.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm delivery <34 weeks
Time Frame: 14 months
Spontaneous labor under 34 weeks.
14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm delivery <37 weeks
Time Frame: 14 months
Spontaneous delivery under 37 weeks
14 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal mortality
Time Frame: 14 months
Dead of the newborn, due to preterm delivery
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad del Desarrollo

Collaborators

Hospital Padre Hurtado
Hospital San Borja-Arriaran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

October 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (ESTIMATE)

August 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 20, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAS149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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