Vaginal Pessary Versus Expectant Management for Placenta Previa

Stopped early · Not applicable

Conditions studied: Placenta Previa

In brief

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.

Key facts

Study ID

NCT01996345

Run by

Pediatrix

People needed

17

Starts

2016-10-01

Expected to finish

2018-09-05

Last updated by the study team

2018-09-27

Who can join

Age: 18 and older, up to 54. Sex: female. Healthy volunteers: not accepted.

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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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