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Progesterone and Cervical Pessary in Twins (PRECEPET)

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ClinicalTrials.gov Identifier: NCT03058536
Recruitment Status : Unknown
Verified February 2017 by Mario Henrique Burlacchini de Carvalho, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : February 23, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Mario Henrique Burlacchini de Carvalho, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Preterm Birth Twin Pregnancy With Antenatal Problem Device: Arabin Pessary Drug: Vaginal Progesterone Other: Arabin Pessary and Progesterone Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 312 twin pregnant women with short cervix between 16 and 27 weeks and 6 days of gestacional age will be randomized in four groups: daily 400mg vaginal progesterone combined with insertion of cervical pessary; isolated use of daily 400mg vaginal progesterone, isolated insertion of cervical pessary or expectant management (no intervention).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Progesterone and Cervical Pessary in Twins : A Prospective and Randomized Study to Prevent Preterm Birth (PRECEPT)
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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 Name: 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



Primary Outcome Measures :
  1. Preterm birth [ Time Frame: 5 months ]
    Rate of preterm birth before 34 weeks gestation


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058536


Contacts
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Contact: Mario Henrique Burlacchini de Carvalho, PhD +55 11 26616209 ext 3183 mario.burlacchini@hc.fm.usp.br
Contact: Carolina Fiuza Branco +55 11 986974207 carolfiuzabranco@hotmail.com

Locations
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Brazil
Hospital das Clinicas da FMUSP Recruiting
Sao Paulo, Brazil
Contact: Mario Henrique Burlacchini de Carvalho, PhD    551126616209    marioburlacchini@uol.com.br   
Sponsors and Collaborators
Mario Henrique Burlacchini de Carvalho
Investigators
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Principal Investigator: Mario Henrique Burlacchini de Carvalho, PhD Hospital das Clínicas Universidade de São Paulo

Publications:

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Responsible Party: Mario Henrique Burlacchini de Carvalho, Professor Doutor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03058536     History of Changes
Other Study ID Numbers: 1.847.411
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mario Henrique Burlacchini de Carvalho, University of Sao Paulo:
twin short cervix pessary progesterone preterm birth

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs