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

Gene Lee, MD

Status: Terminated

Conditions: Premature Birth

Treatments: Device: Arabin Pessary

Study type: Interventional

Funder types: Other

Identifiers

NCT02357394

KUOBGYN001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Device: Arabin Pessary

Experimental group

Description:

Participants randomized to this group will receive the pessary.

Treatment:

Device: Arabin Pessary

Standard of Care

No Intervention group

Description:

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.