Preventing Preterm Birth With a Pessary (PrePPy)

MedStar Health

Status

Withdrawn

Conditions

Preterm Birth

Treatments

Device: Cup pessary (Bioteque America, Inc)

Study type

Interventional

Funder types

Other

Identifiers

NCT01380158

2010-225

Details and patient eligibility

About

The primary objective of this study, is to determine the effect of a Cup pessary, a device that is currently readily available in the USA and similar in design to the Arabin pessary, on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length prior to 23 weeks.

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Singleton pregnancies in patients with a history of spontaneous preterm birth (previous delivery between 17 0/7 weeks and 36 6/7 weeks).
Women ages 18 to 45 years of age

Exclusion criteria

Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), fetal death, or fetal growth restriction diagnosed before randomization.
Presence of prophylactic cervical cerclage
Significant maternal-fetal complications (treated chronic hypertension, insulin dependant diabetes mellitus, red cell isoimmunization)
Painful regular uterine contractions, or ruptured membranes
Visual cervical dilation of 2cm or greater and visible membranes.
Patients with a pregnancy dated by an ultrasound after 20 weeks gestation.