Prevention of Preterm Birth With a Pessary in Twin Gestations



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 50
Updated:5/30/2018
Start Date:February 2014
End Date:October 2016

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Preterm birth (PTB) is a major health problem and contributes to more than 50% of the overall
perinatal mortality. Twins are at increased risk for PTB. The number of twins births has
risen substantially due to the increased use of assisted reproductive technology. The rate of
twin births in the United States rose from 18.9 to 32.2 per 100 live births between 1980 and
2004. The increased rate of PTB in twins is associated with increased morbidity and mortality
rates. Almost one in four very low birth-weight infants (below 1500 g) born in the United
States are twins, as are one in six infants who die in the first month of life. Cervical
shortening is a risk factor for PTB. Transvaginal ultrasound measurement of cervical length
is a reliable screening test for prediction of PTB. There is currently no effective treatment
to decrease the incidence of PTB in women with twin gestations, but there is some evidence
that the use of a cervical pessary in women with a short cervix has promise. If effective
this approach would be particularly appealing because of the wide availability of pessaries,
ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm
effectiveness; a well designed, properly powered, prospective randomized trial is warranted
prior to widespread implementation in clinical practice. We propose such a trial to study the
effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia
population.


Inclusion Criteria:

- 18-50 years of age

- Twin pregnancy (limits the participants to female gender)

- Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at
18-27 6/7 weeks gestation

Exclusion Criteria:

- Singleton or higher order than twins multiple gestation

- Monoamniotic twins

- Twin twin transfusion syndrome

- Ruptured membranes

- Lethal fetal structural anomaly

- Fetal chromosomal abnormality

- Cerclage in place (or planned placement)

- Vaginal bleeding

- Suspicion of chorioamnionitis

- Ballooning of membranes outside the cervix into the vagina

- Painful regular uterine contractions

- Labor

- Placenta previa
We found this trial at
3
sites
111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Philadelphia, PA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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800 Spruce St
Philadelphia, Pennsylvania 19107
215-829-3000
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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Philadelphia, PA
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