Progesterone and Cervical Pessary in Twins (PRECEPET)

March 13, 2017 updated by: Mario Henrique Burlacchini de Carvalho

Progesterone and Cervical Pessary in Twins : A Prospective and Randomized Study to Prevent Preterm Birth (PRECEPT)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The frequency of twin pregnancies has increased significantly, especially because of the assisted reproduction and advanced maternal age at conception. The twin pregnancies are responsible for 25 % of all preterm birth. Consequently, twin pregnancies are more associated with perinatal mortality and morbidity when compared to single pregnancies. Additionally, the short cervix (< 25 mm) in singleton and twin pregnancies are associated with significantly increased preterm birth.

Randomized controlled trials in singleton pregnancies reported that profilatic cervical cerclage and vaginal progesterone reduce significantly the rate of early preterm birth. In twin pregnancies, vaginal progesterone and profilatic cerclage have been shown to be ineffective in prevention of preterm birth.

However, two individual pacient data meta-analyses reported in a subgroup of women with twin pregancies and short cervix, that vaginal progesterone reduce significantly adverse neonatal outcomes. Nowadays, the effet of cervical pessary is contraditory, mainly in women with short cervix.

This is a randomized prospective trial at São Paulo University Medical School. This trial will involve 312 women with twins pregnancies and short cervix between 16 and 27 weeks and 6 days of gestacional age. Women with twin pregnancy and short cervix ( defined according to the gestacional age ) will be assigned randomly to daily vaginal progesterone (400mg) combined with insertion of cervical pessary, isolated use of daily vaginal progesterone (400mg) isolated insertion of cervical pessary or expectant management (no intervention). The primary outcome is to compare the rate of spontaneous delivery < 34 weeks of gestacion between groups.The secondary outcome is to compare the neonatal adverse outcome between the groups.

The aim of this study is to test the hypothesis that the insertion of a cervical pessary combined with vaginal progesterone, in twin pregnancies with short cervix would reduce the spontaneus preterm birth < 34 weeks' gestation.

Study Type

Interventional

Enrollment (Anticipated)

312

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Recruiting
        • Hospital das Clinicas da FMUSP
        • Contact:

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 48 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Twin pregnancy ( dichorionic or monochorionic diamniotic)
  • Both fetuses alive
  • Asymptomatic short cervix according to gestational age ( measurement less or equal 30 mm between 16 weeks + 0 day and 22 weeks + 0 day, less or equal 25 mm between 22 weeks + 1 day and 24 weeks + 0 day and less or equal 20 mm between 24 weeks + 1 day and 27 weeks + 6 days)
  • Gestational age between 16 to 27weeks and 6 days
  • Intact membranes
  • Informed consent

Exclusion Criteria:

  • Monoamniotic twins
  • Twin Twin transfusion syndrome
  • Rupture membranes
  • Major malformation or chromosomal abnormality at least one fetus
  • Women with Cervical cerclage in the current pregnancy
  • Ballooning of membranes outside the cervix into the vagina
  • Placenta previa
  • Treatment with progesterone before randomization
  • Allergy of the excipientes of the micronized progesterone
  • Labor
  • Severe hepatic disfunction, porphyria, otosclerosis, severe depression
  • Use of drugs that interfere the effects of progesterone

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Progesterone
400 mg micronized vaginal progesterone daily from randomization to 36 weeks
Drug: Vaginal Progesterone
Treatment with 400 mg micronized progesterone daily, until the day of randomization to 36 weeks of pregnancy.
Other Names:
  • Utrogestan
Active Comparator: Arabin Pessary and Progesterone

Arabin Pessary and Natural Micronized Progesterone

400 mg micronized vaginal progesterone daily from randomization to 36 weeks

The device will be placed at randomization and will be removed during the 36th week of gestacional (or earlier if indicated) in combination with vaginal progesterone.
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.
Active Comparator: Arabin Pessary
The device will be placed at randomization and will be removed during the 36th week of gestacional (or earlier if indicated) without vaginal progesterone use.
Device: Arabin Pessary
The cervical pessary will be inserted at the randomization and removed during the 36 week of pregnancy, unless labour occurs sooner.
No Intervention: No intervention
Expectant management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm birth
Time Frame: 5 months
Rate of preterm birth before 34 weeks gestation
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Complications Rate
Time Frame: between birth and 28 days of age
Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, retinopathy, sepsis, use of mechanical ventilation, time of hospitalization, and neonatal death.
between birth and 28 days of age
Months from Randomization to delivery interval
Time Frame: 6 months
Randomization may begin at 16 weeks, and most patient will be delivered between 36 and 38 weeks gestation.
6 months

Collaborators and Investigators

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

Sponsor

Mario Henrique Burlacchini de Carvalho

Investigators

  • Principal Investigator: Mario Henrique Burlacchini de Carvalho, PhD, Hospital das Clínicas Universidade de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 21, 2017

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

February 5, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.847.411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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