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Progesterone and Cervical Pessary in Twins

NCT03058536 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2017-03-15

No results posted yet for this study

Summary

The aim of this randomized control trial is to determine wheter cervical pessary plus vaginal progesterone (400mg) reduce preterm birth less than 34 weeks of gestacion and improve perinatal outcome, among women presenting asyntomatic short cervix, in twin pregnancy.

Conditions

Interventions

DEVICE

Arabin Pessary

The cervical pessary will be inserted at the randomization and removed during the 36 week of pregnancy, unless labour occurs sooner.

DRUG

Vaginal Progesterone

Treatment with 400 mg micronized progesterone daily, until the day of randomization to 36 weeks of pregnancy.

OTHER

Arabin Pessary and Progesterone

Arabin Pessary and Progesterone The cervical pessary will be inserted at the randomization and removed during the 36 week of pregnancy, unless labour occurs sooner. Treatment with 400 mg Micronized progesterone daily, until the day of randomization to 36 weeks of pregnancy.

Sponsors & Collaborators

  • Mario Henrique Burlacchini de Carvalho

    lead OTHER

Principal Investigators

  • Mario Henrique Burlacchini de Carvalho, PhD · Hospital das Clínicas Universidade de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2019-03-31
Completion
2019-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03058536 on ClinicalTrials.gov