Preventing Preterm Birth With a Pessary (PrePPy)

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.

Study Overview

• Status: Withdrawn
• Conditions: Preterm Birth
• Intervention / Treatment: Device: Cup pessary (Bioteque America, Inc)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Franklin Square Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Previable birth (<24 weeks)	Gestational age at birth will be recorded	within the first 30 days after delivery of the neonate
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
Low birth weight	Birthweight at delivery will be recorded	within the first 30 days after delivery of the neonate
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
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
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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Investigators: Principal Investigator: Rita W Driggers, MD, MedStar Health Research Institute

Publications and helpful links

General 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. doi: 10.1056/NEJM199602293340904.
• 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.
• 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. doi: 10.1056/NEJMoa035140. Erratum In: N Engl J Med. 2003 Sep 25;349(13):1299.
• Arabin B, Halbesma JR, Vork F, Hubener 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. doi: 10.1515/JPM.2003.017.
• Vitsky M. Pessary treatment of the incompetent cervical os. Obstet Gynecol. 1968 May;31(5):732-3. doi: 10.1097/00006250-196805000-00024. No abstract available.
• Oster S, Javert CT. Treatment of the incompetent cervix with the Hodge pessary. Obstet Gynecol. 1966 Aug;28(2):206-8. doi: 10.1097/00003081-196608000-00011. No abstract available.
• Antczak-Judycka A, Sawicki W, Spiewankiewicz B, Cendrowski K, Stelmachow 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: June 15, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: preterm birth; short cervix; pessary; cervical incompetence
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2010-225