Vaginal Pessary Versus Expectant Management for Placenta Previa

NCT ID: NCT01996345

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-09-05

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.

Conditions

Placenta Previa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cervical Pessary Placement

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Obstetrix Medical Group

INDUSTRY

Sponsor Role: collaborator

Pediatrix

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Garite, MD

Role: PRINCIPAL_INVESTIGATOR

Obstetrix Medical Group

Irene Stafford, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

University of South Alabama Medical Center

Mobile, Alabama, United States

Long Beach Memorial Medical Center

Long Beach, California, United States

Good Samaritan Hospital

San Jose, California, United States

Presbyterian/St Luke's Hospital

Denver, Colorado, United States

Denver Health and Hospital Authority

Denver, Colorado, United States

Norton Kosair Children's Hospital

Louisville, Kentucky, United States

Tulane - Lakeside Hospital for Women and Children

Metairie, Louisiana, United States

Touro Infirmary

New Orleans, Louisiana, United States

Baylor/Texas Children's Hospital & Pavilion

Houston, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Countries

United States

Related Links

http://pediatrix.com

Sponsors Website

Other Identifiers

OBX0028

Identifier Type: -

Identifier Source: org_study_id