Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix: an Open-label Randomized Controlled Trial

Gene Lee, MD2 sites in 1 country7 target enrollmentMay 2015

ConditionsPremature Birth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Premature Birth
Sponsor: Gene Lee, MD
Enrollment: 7
Locations: 2
Primary Endpoint: Preterm Birth Before 37 Weeks
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

April 1, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Gene Lee, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Gene Lee, MD

Assistant Professor

University of Kansas Medical Center

Eligibility Criteria

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)

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)