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Completed

NCT Number: NCT02716909

Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.

The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Gabriele Saccone

Naples, 80129, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-50 years of age
  • Singleton pregnancy (limits the participants to female gender)
  • Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation

Exclusion criteria

  • Multiple gestation
  • Prior spontaneous preterm birth 16-36 6/7 weeks
  • Ruptured membranes
  • Lethal fetal structural anomaly
  • Fetal chromosomal abnormality
  • Cerclage in place (or planned placement)
  • Vaginal bleeding
  • Suspicion of chorioamnionitis
  • Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
  • Painful regular uterine contractions
  • Placenta previa

Treatment and study plan

Cervical pessary

Device

The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)

Primary outcomes

  1. Spontaneous preterm birth (SPTB) <34 weeks

    Time frame: Less than 34 weeks gestation

    Spontaneous preterm delivery less than 34 weeks of gestation

Secondary outcomes

  1. SPTB <37w

    Time frame: Less than 37 weeks gestation

  2. SPTB <32w

    Time frame: Less than 32 weeks gestation

  3. SPTB <28w

    Time frame: Less than 32 weeks gestation

  4. Gestational age at delivery

    Time frame: Time of delivery

  5. Latency

    Time frame: time of delivery

    interval from randomization to delivery in days

  6. preterm premature rupture of membranes

    Time frame: Less than 34 weeks gestation

  7. Type of delivery

    Time frame: time of delivery

    Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery

  8. Maternal side effects

    Time frame: Time of delivery

    Vaginal discharge, bacterial vaginosis

  9. Birth weight

    Time frame: Time of delivery

  10. Neonatal death

    Time frame: Between birth and 28 days of age

  11. perinatal death

    Time frame: fetal death after 20 weeks

    either fetal mortality or neonatal death

  12. Composite adverse perinatal outcome

    Time frame: Between birth and 28 days of age

    Includes necrotizing enterocolitis, Intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis, and neonatal death

  13. Chorioamnionitis

    Time frame: Time of delivery

  14. Adminssion to neonatal intensive care unit

    Time frame: Between birth and 28 days of age

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2016
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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