Preventing Preterm Birth With a Pessary

Withdrawn before enrolling · Not applicable

Conditions studied: Preterm Birth

In brief

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.

Key facts

Study ID

NCT01380158

Run by

Medstar Health Research Institute

People needed

0

Starts

2011-01-01

Last updated by the study team

2021-02-17

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Franklin Square Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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