PrePPy: Preventing Preterm Birth With a Pessary
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pessary use during pregnancy Device: Cup pessary |
Device: Cup pessary (Bioteque America, Inc)
Placement of cup pessary in the vagina after randomization
|
| No Intervention: Expectant management Expectant Management + weekly intramuscular progesterone injections |
Outcome Measures
Primary Outcome Measures
- delivery prior to 37 weeks of gestation [within the first 30 days after delivery of the neonate]
Gestational age at birth will be recorded
Secondary Outcome Measures
- Rate of birth less than seven days from randomization [within the first 30 days after delivery of the neonate]
Gestational age at birth will be recorded
- Previable birth (<24 weeks) [within the first 30 days after delivery of the neonate]
Gestational age at birth will be recorded
- Perinatal death [participants will be followed for the duration of hospital stay, an expected average of 4 weeks]
defined as either a stillbirth or postnatal death prior to hospital discharge
- Low birth weight [within the first 30 days after delivery of the neonate]
Birthweight at delivery will be recorded
- Major adverse neonatal outcomes [participants will be followed for the duration of hospital stay, an expected average of 4 weeks]
intraventricular hemorrhage, respiratory distress syndrome of the newborn, retinopathy of prematurity, or necrotizing enterocolitis
- Need for neonatal special care [participants will be followed for the duration of hospital stay, an expected average of 4 weeks]
ventilation, phototherapy, treatment for sepsis, blood transfusion
- Incidence of complications due to pessary [Every 4 weeks while pregnant with pessary in situ]
Incidence of bacterial vaginosis, urinary tract infections, vaginal erosions will be recorded at monthly visits.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 2 | Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 3 | Franklin Square Hospital | Baltimore | Maryland | United States | 21237 |
Sponsors and Collaborators
- Medstar Health Research Institute
Investigators
- Principal Investigator: Rita W Driggers, MD, Medstar Health Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Antczak-Judycka A, Sawicki W, Spiewankiewicz B, Cendrowski K, Stelmachów J. [Comparison of cerclage and cerclage pessary in the treatment of pregnant women with incompetent cervix and threatened preterm delivery]. Ginekol Pol. 2003 Oct;74(10):1029-36. Polish.
- Arabin B, Halbesma JR, Vork F, Hübener M, van Eyck J. Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix? J Perinat Med. 2003;31(2):122-33.
- Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72.
- Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003 Jun 12;348(24):2379-85. Erratum in: N Engl J Med. 2003 Sep 25;349(13):1299.
- Oster S, Javert CT. Treatment of the incompetent cervix with the Hodge pessary. Obstet Gynecol. 1966 Aug;28(2):206-8.
- Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, Egerman RS, Wing DA, Tomlinson M, Silver R, Ramin SM, Guzman ER, Gordon M, How HY, Knudtson EJ, Szychowski JM, Cliver S, Hauth JC. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol. 2009 Oct;201(4):375.e1-8. doi: 10.1016/j.ajog.2009.08.015.
- Vitsky M. Pessary treatment of the incompetent cervical os. Obstet Gynecol. 1968 May;31(5):732-3.
- 2010-225