Preventing Preterm Birth With a Pessary



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 45
Updated:4/2/2016
Start Date:January 2011
Contact:Jasbir Singh, MD
Email:jasbir.singh@medstar.net
Phone:202-877-3067

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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.


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.
We found this trial at
3
sites
Wasghington, District of Columbia 20007
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from
Wasghington,
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Baltimore, Maryland 21237
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from
Baltimore, MD
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Wasghinton, District of Columbia 20010
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mi
from
Wasghinton,
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