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Vaginal Pessary Versus Expectant Management for Placenta Previa

Primary Purpose

Placenta Previa

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cervical Pessary Placement
Sponsored by
Pediatrix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Placenta Previa focused on measuring Placenta Previa, Vaginal Pessary, Premature Birth

Eligibility Criteria

18 Years - 54 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant age 18 years or older
  • Gestational age between 22w0d and 32w0d, inclusive, at time of enrollment
  • Singleton pregnancy
  • Complete Placenta Previa
  • Intact Membranes
  • No allergies to material in pessary
  • Plan to deliver at PI's hospital
  • Informed consent obtained, signed/dated

Exclusion Criteria:

  • Active preterm labor
  • Nonreassuring fetal heart rate tracing
  • Intrauterine fetal death
  • Active bleeding (may be enrolled if hemostatic >48 hours)
  • Ruptured membranes
  • Any fetal condition likely to cause serious neonatal morbidity independent of gestational age: Fetal malformation likely to require surgery, Fetal malformation involving vital organs, Fetal viral infection, Hydrops fetalis,
  • Known Uterine Anomaly
  • Cervical Cerclage present at time of enrollment
  • Maternal condition that warrant continued hospitalization (example severe preeclampsia, Diabetes out of control, maternal heart disease)

Sites / Locations

  • University of South Alabama Medical Center
  • Long Beach Memorial Medical Center
  • Good Samaritan Hospital
  • Presbyterian/St Luke's Hospital
  • Denver Health and Hospital Authority
  • Norton Kosair Children's Hospital
  • Tulane - Lakeside Hospital for Women and Children
  • Touro Infirmary
  • Baylor/Texas Children's Hospital & Pavilion
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cervical Pessary Placement

Expectant Managment

Arm Description

For the patients assigned to receive a cervical pessary, they will be evaluated and fitted for a pessary by the physician within 3-4 days unless exclusion criteria develop. After it is placed she will be evaluated for comfort. She will be asked to leave it in at all times but informed that removal and withdrawal from the study is always her option.

Each participant will have standard care for placenta previa. This is the same care that a patient with a placenta previa would ordinarily receive even if she were not participating in the trial. The trial's participating investigators agree that the management outlined in this section is standard management for placenta previa.

Outcomes

Primary Outcome Measures

Decrease Delivery Prior to 36 weeks in patients with a gestational age of 22.0- 32.0 presenting with placenta previa.
This outcome, a decrease in the number of delivery that occur before 36 weeks of pregnancy who have a diagnosed placenta previa. The gestational age is noted at the time of birth.

Secondary Outcome Measures

Need for packed red blood cells or hematologic product replacement
note the number of blood transfusions the baby received from birth until 60 days post birth
Neonate or Fetal Death
death of fetus or newborn up to 60 days post delivery
Neonatal Outcomes
Including birthweight, neonatal death, composite neonatal morbidity (any of the following: respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death.) and specific neonatal morbidities including: Apgar <3 at 5 min, ICU admission, , cord pH, 7.1.
Any adverse reactions to the cervical pessary.
unexpected adverse reaction such as cervical trauma, infection, allergy

Full Information

First Posted
November 14, 2013
Last Updated
September 25, 2018
Sponsor
Pediatrix
Collaborators
Obstetrix Medical Group
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1. Study Identification

Unique Protocol Identification Number
NCT01996345
Brief Title
Vaginal Pessary Versus Expectant Management for Placenta Previa
Official Title
Vaginal Pessary Versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women With Placenta Previa
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated early do to a business decision by sponsor and lack of ability to recruit the needed number of participants.
Study Start Date
October 2016 (Actual)
Primary Completion Date
September 5, 2018 (Actual)
Study Completion Date
September 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pediatrix
Collaborators
Obstetrix Medical Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to perform a large multi-center randomized trial comparing the role of vaginal pessary versus expectant management in women with placenta previa between 22w0d and 32w0d of gestation in prolonging gestation until ≥36 weeks. Secondary outcomes will assess duration of antepartum admission, total blood loss, gestational age at delivery, type of cesarean delivery, and a composite neonatal outcome. The hypothesis is that the use of a vaginal pessary in patients presenting with placenta previa between 22-32 weeks will decrease delivery prior to 36 weeks as compared to expectantly managing these patients.
Detailed Description
While the use of pessary in this scenario has not been previously assessed, it is reasonable to infer, from the data for use of pessary to prevent preterm birth, and the data regarding the efficacy of cervical cerclage in reducing bleeding and preterm birth in patients with placenta previa to this clinical conundrum. If cerclage improves pregnancy outcomes in patients with placenta previa, the use of a vaginal pessary should be a less-invasive but similarly efficacious alternative to maintain cervical length. The purpose of this study is to compare two treatment options reasonably used in clinical practice. Use of cervical pessary is not expected to increase antenatal costs beyond the minimal cost of the pessary. Additionally, given the results of the available clinical trials on cerclage maintaining cervical length and decreasing bleeding, this procedure has the potential to decrease the cost of both antepartum admissions for bleeding and neonatal care. A substantial number of women with placenta previa will not hemorrhage until they reach the third trimester, thus, by allowing for enrollment and pessary placement as late as 32w0d, the intervention may be applied to the broadest "at risk" population. As previously mentioned literature on the use of cerclage in patients with placenta previa and short cervix are limited by a reduced number of eligible subjects and concern over safety issues has not been assuaged by these small studies. As pessary placement appears to carry little if any risk based on a number of published studies, eligibility can be expanded to any cervical length.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa
Keywords
Placenta Previa, Vaginal Pessary, Premature Birth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
There is no masking in this study.
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical Pessary Placement
Arm Type
Experimental
Arm Description
For the patients assigned to receive a cervical pessary, they will be evaluated and fitted for a pessary by the physician within 3-4 days unless exclusion criteria develop. After it is placed she will be evaluated for comfort. She will be asked to leave it in at all times but informed that removal and withdrawal from the study is always her option.
Arm Title
Expectant Managment
Arm Type
No Intervention
Arm Description
Each participant will have standard care for placenta previa. This is the same care that a patient with a placenta previa would ordinarily receive even if she were not participating in the trial. The trial's participating investigators agree that the management outlined in this section is standard management for placenta previa.
Intervention Type
Procedure
Intervention Name(s)
Cervical Pessary Placement
Intervention Description
For the patients assigned to receive a cervical pessary, they will be evaluated and fitted for a pessary by the physician within 3-4 days unless exclusion criteria develop. After it is placed she will be evaluated for comfort. She will be asked to leave it in at all times but informed that removal and withdrawal from the study is always her option.
Primary Outcome Measure Information:
Title
Decrease Delivery Prior to 36 weeks in patients with a gestational age of 22.0- 32.0 presenting with placenta previa.
Description
This outcome, a decrease in the number of delivery that occur before 36 weeks of pregnancy who have a diagnosed placenta previa. The gestational age is noted at the time of birth.
Time Frame
day of birth
Secondary Outcome Measure Information:
Title
Need for packed red blood cells or hematologic product replacement
Description
note the number of blood transfusions the baby received from birth until 60 days post birth
Time Frame
from birth to 60 days
Title
Neonate or Fetal Death
Description
death of fetus or newborn up to 60 days post delivery
Time Frame
From time of trial entry to 60 days post birth (approximately 34 weeks)
Title
Neonatal Outcomes
Description
Including birthweight, neonatal death, composite neonatal morbidity (any of the following: respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death.) and specific neonatal morbidities including: Apgar <3 at 5 min, ICU admission, , cord pH, 7.1.
Time Frame
From Birth to 60 days of Age
Title
Any adverse reactions to the cervical pessary.
Description
unexpected adverse reaction such as cervical trauma, infection, allergy
Time Frame
from 0 to as many as 18 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant age 18 years or older Gestational age between 22w0d and 32w0d, inclusive, at time of enrollment Singleton pregnancy Complete Placenta Previa Intact Membranes No allergies to material in pessary Plan to deliver at PI's hospital Informed consent obtained, signed/dated Exclusion Criteria: Active preterm labor Nonreassuring fetal heart rate tracing Intrauterine fetal death Active bleeding (may be enrolled if hemostatic >48 hours) Ruptured membranes Any fetal condition likely to cause serious neonatal morbidity independent of gestational age: Fetal malformation likely to require surgery, Fetal malformation involving vital organs, Fetal viral infection, Hydrops fetalis, Known Uterine Anomaly Cervical Cerclage present at time of enrollment Maternal condition that warrant continued hospitalization (example severe preeclampsia, Diabetes out of control, maternal heart disease)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Garite, MD
Organizational Affiliation
Obstetrix Medical Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irene Stafford, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90801-1428
Country
United States
Facility Name
Good Samaritan Hospital
City
San Jose
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Presbyterian/St Luke's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
95008
Country
United States
Facility Name
Norton Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane - Lakeside Hospital for Women and Children
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Touro Infirmary
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Baylor/Texas Children's Hospital & Pavilion
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://pediatrix.com
Description
Sponsors Website

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Vaginal Pessary Versus Expectant Management for Placenta Previa

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