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 |
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.
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.
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