Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix: an Open-label Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 7
- Locations
- 4
- Primary Endpoint
- Preterm Birth Before 37 Weeks
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Device: Arabin Pessary
Participants randomized to this group will receive the pessary.
Intervention: Arabin Pessary (Device)
Standard of Care
Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage.
Outcomes
Primary Outcomes
Preterm Birth Before 37 Weeks
Time Frame: Up to 37 weeks 0 days
Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.
Secondary Outcomes
- Admission to Neonatal Intensive Care Unit(participants will be followed for the duration of hospital stay, up to 17 weeks after delivery)
- Total Days in the Neonatal Intensive Care Unit(participants will be followed for the duration of hospital stay, up to 17 weeks after delivery)
- Retinopathy of Prematurity Requiring Treatment(participants will be followed for the duration of hospital stay, up to 17 weeks after delivery)
- Use of Antenatal Steroids(participants will be followed for the duration of pregnancy, up to nine months)
- Vaginal Bleeding(participants will be followed for the duration of pregnancy, up to nine months)
- Preterm Birth Before 34 Weeks(up to 34 weeks 0 days)
- Neonatal Composite Morbidity(antepartum and up to 28 days after postnatal gestational age of 36 weeks)
- Preterm Premature Rupture of Membranes(participants will be followed for the duration of pregnancy, up to nine months)
- Neonatal Length of Stay(participants will be followed for the duration of hospital stay, up to 17 weeks after delivery)
- Duration of Ventilator Support(participants will be followed for the duration of hospital stay, up to 17 weeks after delivery)
- Birthweight < 1500 Grams(at time of birth, expected to be within 4 weeks of due date)
- Birthweight < 2500 Grams(at time of birth, expected to be within 4 weeks of due date)
- Gestational Age at Delivery(at time of birth, expected to be within 4 weeks of due date)
- Chorioamnionitis(participants will be followed for the duration of pregnancy, up to nine months)
- Cesarean Delivery(at time of delivery, expected to be within 4 weeks of due date)
- Use of Tocolysis(participants will be followed for the duration of pregnancy, up to nine months)
Investigators
Gene Lee, MD
Assistant Professor
University of Kansas Medical Center