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Preventing Preterm Birth With a Pessary (PrePPy)

Primary Purpose

Preterm Birth

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cup pessary (Bioteque America, Inc)
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring pessary, preterm birth, short cervix, cervical incompetence

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Georgetown University Hospital
  • Washington Hospital Center
  • Franklin Square Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pessary use during pregnancy

Expectant management

Arm Description

Device: Cup pessary

Expectant Management + weekly intramuscular progesterone injections

Outcomes

Primary Outcome Measures

delivery prior to 37 weeks of gestation
Gestational age at birth will be recorded

Secondary Outcome Measures

Rate of birth less than seven days from randomization
Gestational age at birth will be recorded
Previable birth (<24 weeks)
Gestational age at birth will be recorded
Perinatal death
defined as either a stillbirth or postnatal death prior to hospital discharge
Low birth weight
Birthweight at delivery will be recorded
Major adverse neonatal outcomes
intraventricular hemorrhage, respiratory distress syndrome of the newborn, retinopathy of prematurity, or necrotizing enterocolitis
Need for neonatal special care
ventilation, phototherapy, treatment for sepsis, blood transfusion
Incidence of complications due to pessary
Incidence of bacterial vaginosis, urinary tract infections, vaginal erosions will be recorded at monthly visits.

Full Information

First Posted
June 15, 2011
Last Updated
February 15, 2021
Sponsor
Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01380158
Brief Title
Preventing Preterm Birth With a Pessary
Acronym
PrePPy
Official Title
Preventing Preterm Birth With a Pessary
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Withdrawn
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
pessary, preterm birth, short cervix, cervical incompetence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pessary use during pregnancy
Arm Type
Experimental
Arm Description
Device: Cup pessary
Arm Title
Expectant management
Arm Type
No Intervention
Arm Description
Expectant Management + weekly intramuscular progesterone injections
Intervention Type
Device
Intervention Name(s)
Cup pessary (Bioteque America, Inc)
Intervention Description
Placement of cup pessary in the vagina after randomization
Primary Outcome Measure Information:
Title
delivery prior to 37 weeks of gestation
Description
Gestational age at birth will be recorded
Time Frame
within the first 30 days after delivery of the neonate
Secondary Outcome Measure Information:
Title
Rate of birth less than seven days from randomization
Description
Gestational age at birth will be recorded
Time Frame
within the first 30 days after delivery of the neonate
Title
Previable birth (<24 weeks)
Description
Gestational age at birth will be recorded
Time Frame
within the first 30 days after delivery of the neonate
Title
Perinatal death
Description
defined as either a stillbirth or postnatal death prior to hospital discharge
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Low birth weight
Description
Birthweight at delivery will be recorded
Time Frame
within the first 30 days after delivery of the neonate
Title
Major adverse neonatal outcomes
Description
intraventricular hemorrhage, respiratory distress syndrome of the newborn, retinopathy of prematurity, or necrotizing enterocolitis
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Need for neonatal special care
Description
ventilation, phototherapy, treatment for sepsis, blood transfusion
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Incidence of complications due to pessary
Description
Incidence of bacterial vaginosis, urinary tract infections, vaginal erosions will be recorded at monthly visits.
Time Frame
Every 4 weeks while pregnant with pessary in situ

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita W Driggers, MD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Franklin Square Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8569824
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. doi: 10.1056/NEJM199602293340904.
Results Reference
background
PubMed Identifier
19788970
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.
Results Reference
background
PubMed Identifier
12802023
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. doi: 10.1056/NEJMoa035140. Erratum In: N Engl J Med. 2003 Sep 25;349(13):1299.
Results Reference
background
PubMed Identifier
5646408
Citation
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.
Results Reference
background
PubMed Identifier
5944837
Citation
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.
Results Reference
background
PubMed Identifier
12747228
Citation
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.
Results Reference
background
PubMed Identifier
14669390
Citation
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.
Results Reference
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Preventing Preterm Birth With a Pessary

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