Preventing Preterm Birth With a Pessary - Full Text View

Purpose

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	Intervention
Preterm Birth	Device: Cup pessary (Bioteque America, Inc)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
Official Title:	Preventing Preterm Birth With a Pessary

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:

delivery prior to 37 weeks of gestation [ Time Frame: within the first 30 days after delivery of the neonate ] [ Designated as safety issue: Yes ]
Gestational age at birth will be recorded

Secondary Outcome Measures:

Rate of birth less than seven days from randomization [ Time Frame: within the first 30 days after delivery of the neonate ] [ Designated as safety issue: Yes ]
Gestational age at birth will be recorded
Previable birth (<24 weeks) [ Time Frame: within the first 30 days after delivery of the neonate ] [ Designated as safety issue: Yes ]
Gestational age at birth will be recorded
Perinatal death [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: Yes ]
defined as either a stillbirth or postnatal death prior to hospital discharge
Low birth weight [ Time Frame: within the first 30 days after delivery of the neonate ] [ Designated as safety issue: No ]
Birthweight at delivery will be recorded
Major adverse neonatal outcomes [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
intraventricular hemorrhage, respiratory distress syndrome of the newborn, retinopathy of prematurity, or necrotizing enterocolitis
Need for neonatal special care [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
ventilation, phototherapy, treatment for sepsis, blood transfusion
Incidence of complications due to pessary [ Time Frame: Every 4 weeks while pregnant with pessary in situ ] [ Designated as safety issue: Yes ]
Incidence of bacterial vaginosis, urinary tract infections, vaginal erosions will be recorded at monthly visits.

Estimated Enrollment:	238
Study Start Date:	January 2011
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380158

Contacts

Contact: Jasbir Singh, MD	202-877-3067	jasbir.singh@medstar.net
Contact: Rita W. Driggers, MD	202-877-7127	rita.w.driggers@medstar.net

Locations

United States, District of Columbia
Georgetown University Hospital	Recruiting
Wasghington, District of Columbia, United States, 20007
Contact: Helain Landy, MD 202-444-8757 helain.j.landy@m3dstar.net
Principal Investigator: Helain J Landy, MD
Washington Hospital Center	Recruiting
Wasghinton, District of Columbia, United States, 20010
Contact: Jasbir Singh, MD 202-877-3067 jasbir.singh@medstar.net
Sub-Investigator: Jasbir Singh, MD
Principal Investigator: Rita W Driggers, MD
United States, Maryland
Franklin Square Hospital	Recruiting
Baltimore, Maryland, United States, 21237
Contact: Samuel Smith, MD 443-777-8045 samuel.smith@medstar.net
Principal Investigator: Samuel Smith, MD

Sponsors and Collaborators

Medstar Research Institute

Washington Hospital Center

Investigators

Principal Investigator:

Rita W Driggers, MD

Washington Hospital Center

More Information

Publications:

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.

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.

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.

Vitsky M. Pessary treatment of the incompetent cervical os. Obstet Gynecol. 1968 May;31(5):732-3. No abstract available.

Oster S, Javert CT. Treatment of the incompetent cervix with the Hodge pessary. Obstet Gynecol. 1966 Aug;28(2):206-8. No abstract available.

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.

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.

Responsible Party:	Jasbir Singh, MD, Washington Hospital Center
ClinicalTrials.gov Identifier:	NCT01380158 History of Changes
Other Study ID Numbers:	2010-225
Study First Received:	June 15, 2011
Last Updated:	July 7, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Medstar Research Institute:

pessary
preterm birth
short cervix
cervical incompetence

Additional relevant MeSH terms:

Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013

Preventing Preterm Birth With a Pessary (PrePPy)