Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix

Gene Lee, MD7 enrolled

Overview

The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.

This is an open label randomized controlled study. The pessary will be offered to those patients who have a transvaginal cervical length less than 25 mm before 23 weeks 0 days. The control group will receive the current standard of care which includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. The primary outcome of the study is preterm delivery less than 37 weeks 0 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Premature Birth

Interventions

Arabin PessaryDEVICE

Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * singleton * cervical length \< 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days * agrees to refrain from sexual intercourse Exclusion Criteria: * major fetal anomalies * painful regular uterine contractions * active vaginal bleeding * ruptured membranes * evidence of chorioamnionitis or other maternal/fetal infectious morbidity * placenta previa * cervical cerclage in situ * visual cervical dilation of 2 cm or greater with visible amnion/chorion * significant maternal-fetal complications (chronic hypertension, insulin dependent diabetes mellitus, systemic lupus erythematosus with nephritis, chronic hypertension, red cell alloimmunization, drug abuse)

Locations (2)

University of Kansas Medical Center

Kansas City, Kansas, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Preterm Birth Before 37 Weeks

Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.

Time frame: Up to 37 weeks 0 days

Secondary Outcomes

Preterm Birth Before 34 Weeks

Number of deliveries before 34 weeks 0 days of gestation

Time frame: up to 34 weeks 0 days

Neonatal Composite Morbidity

Count of Fetal or Neonatal death up to 28 days after birth, respiratory distress syndrome, chronic lung disease, periventricular lucency, periventricular leukomalacia, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis, early-onset-culture-proven sepsis

Time frame: antepartum and up to 28 days after postnatal gestational age of 36 weeks

Neonatal Length of Stay

Total number of days in hospital after birth

Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery

Admission to Neonatal Intensive Care Unit

Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay.

Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery

Total Days in the Neonatal Intensive Care Unit

Number of days a baby spends in the neonatal intensive care unit

Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery

Duration of Ventilator Support

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.