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Trial record 1 of 1 for:    NCT01996345
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Vaginal Pessary Versus Expectant Management for Placenta Previa

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ClinicalTrials.gov Identifier: NCT01996345
Recruitment Status : Terminated (Study was terminated early do to a business decision by sponsor and lack of ability to recruit the needed number of participants.)
First Posted : November 27, 2013
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
Obstetrix Medical Group
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

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.

Condition or disease Intervention/treatment Phase
Placenta Previa Procedure: Cervical Pessary Placement Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: There is no masking in this study.
Primary Purpose: Treatment
Official Title: Vaginal Pessary Versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women With Placenta Previa
Actual Study Start Date : October 2016
Actual Primary Completion Date : September 5, 2018
Actual Study Completion Date : September 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cervical Pessary Placement
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.
Procedure: Cervical Pessary Placement
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.

No Intervention: Expectant Managment
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.



Primary Outcome Measures :
  1. Decrease Delivery Prior to 36 weeks in patients with a gestational age of 22.0- 32.0 presenting with placenta previa. [ Time Frame: day of birth ]
    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 :
  1. Need for packed red blood cells or hematologic product replacement [ Time Frame: from birth to 60 days ]
    note the number of blood transfusions the baby received from birth until 60 days post birth

  2. Neonate or Fetal Death [ Time Frame: From time of trial entry to 60 days post birth (approximately 34 weeks) ]
    death of fetus or newborn up to 60 days post delivery

  3. Neonatal Outcomes [ Time Frame: From Birth to 60 days of Age ]
    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.

  4. Any adverse reactions to the cervical pessary. [ Time Frame: from 0 to as many as 18 weeks. ]
    unexpected adverse reaction such as cervical trauma, infection, allergy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996345


Locations
United States, Alabama
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90801-1428
Good Samaritan Hospital
San Jose, California, United States, 95008
United States, Colorado
Presbyterian/St Luke's Hospital
Denver, Colorado, United States, 80218
Denver Health and Hospital Authority
Denver, Colorado, United States, 95008
United States, Kentucky
Norton Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane - Lakeside Hospital for Women and Children
Metairie, Louisiana, United States, 70001
Touro Infirmary
New Orleans, Louisiana, United States, 70115
United States, Texas
Baylor/Texas Children's Hospital & Pavilion
Houston, Texas, United States, 77030
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122-4307
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
Obstetrix Medical Group
Investigators
Principal Investigator: Thomas Garite, MD Obstetrix Medical Group
Principal Investigator: Irene Stafford, MD Baylor College of Medicine

Additional Information:
Responsible Party: Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier: NCT01996345     History of Changes
Other Study ID Numbers: OBX0028
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mednax Center for Research, Education, Quality and Safety:
Placenta Previa
Vaginal Pessary
Premature Birth

Additional relevant MeSH terms:
Placenta Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases