Preventing Preterm Birth With a Pessary

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Pessary use during pregnancy

Device: Cup pessary

Group Type EXPERIMENTAL

Cup pessary (Bioteque America, Inc)

Intervention Type DEVICE

Placement of cup pessary in the vagina after randomization

Expectant management

Expectant Management + weekly intramuscular progesterone injections

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cup pessary (Bioteque America, Inc)

Placement of cup pessary in the vagina after randomization

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes