Vaginal Pessary Versus Expectant Management for Placenta Previa

NCT01996345 | Terminated DMC

• 1 other identifier: OBX0028
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 10

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.

Conditions

Placenta Previa

Keywords

Placenta Previa; Vaginal Pessary; Premature Birth

Outcome Measures

Primary Outcomes (1)

• 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.

  day of birth

Secondary Outcomes (4)

• Need for packed red blood cells or hematologic product replacement

  from birth to 60 days

• Neonate or Fetal Death

  From time of trial entry to 60 days post birth (approximately 34 weeks)

• Neonatal Outcomes

  From Birth to 60 days of Age

• Any adverse reactions to the cervical pessary.

  from 0 to as many as 18 weeks.

Study Arms (2)

Cervical Pessary Placement

EXPERIMENTAL

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

Expectant Managment

NO INTERVENTION

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.

Interventions

Cervical Pessary Placement 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.

Cervical Pessary Placement

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pediatrix: lead
• Obstetrix Medical Group: collaborator

Study Sites (10)

University of South Alabama Medical Center

Mobile, Alabama, 36617, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90801-1428, United States

Location

Good Samaritan Hospital

San Jose, California, 95008, United States

Location

Presbyterian/St Luke's Hospital

Denver, Colorado, 80218, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 95008, United States

Location

Norton Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Tulane - Lakeside Hospital for Women and Children

Metairie, Louisiana, 70001, United States

Location

Touro Infirmary

New Orleans, Louisiana, 70115, United States

Location

Baylor/Texas Children's Hospital & Pavilion

Houston, Texas, 77030, United States

Location

Swedish Medical Center

Seattle, Washington, 98122-4307, United States

Location

Related Links

• Sponsors Website

MeSH Terms

Conditions

Placenta Previa; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Obstetric Labor, Premature

Study Officials

• Thomas Garite, MD

  Obstetrix Medical Group

  PRINCIPAL INVESTIGATOR

• Irene Stafford, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 27, 2013
• Study Start: October 1, 2016
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

US (10)