Preventing Preterm Birth With a Pessary

Preterm Birth Clinical Trial

— PrePPy  

Official title:

Preventing Preterm Birth With a Pessary

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01380158
• Other study ID #: 2010-225
• Status: Withdrawn
• Phase: N/A
• Start date: January 2011

Study information

• Verified date: June 2011
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Device:
• Cup pessary (Bioteque America, Inc)
Placement of cup pessary in the vagina after randomization

Locations

Country	Name	City	State
United States	Franklin Square Hospital	Baltimore	Maryland
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Oster S, Javert CT. Treatment of the incompetent cervix with the Hodge pessary. Obstet Gynecol. 1966 Aug;28(2):206-8. — View Citation

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. — View Citation

Vitsky M. Pessary treatment of the incompetent cervical os. Obstet Gynecol. 1968 May;31(5):732-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delivery prior to 37 weeks of gestation	Gestational age at birth will be recorded	within the first 30 days after delivery of the neonate
Secondary	Rate of birth less than seven days from randomization	Gestational age at birth will be recorded	within the first 30 days after delivery of the neonate
Secondary	Previable birth (<24 weeks)	Gestational age at birth will be recorded	within the first 30 days after delivery of the neonate
Secondary	Perinatal death	defined as either a stillbirth or postnatal death prior to hospital discharge	participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary	Low birth weight	Birthweight at delivery will be recorded	within the first 30 days after delivery of the neonate
Secondary	Major adverse neonatal outcomes	intraventricular hemorrhage, respiratory distress syndrome of the newborn, retinopathy of prematurity, or necrotizing enterocolitis	participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary	Need for neonatal special care	ventilation, phototherapy, treatment for sepsis, blood transfusion	participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary	Incidence of complications due to pessary	Incidence of bacterial vaginosis, urinary tract infections, vaginal erosions will be recorded at monthly visits.	Every 4 weeks while pregnant with pessary in situ