NCT03058536

Progesterone and Cervical Pessary in Twins

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Mario Henrique Burlacchini de Carvalho · Academic / Other
• Sex: Female
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Preterm Birth
• Twin Pregnancy With Antenatal Problem

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-21
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2017-02-23
• Last updated: 2017-03-15

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study
• FDA-regulated device study