Vaginal Pessary Versus Expectant Management for Placenta Previa
Placenta Previa
About this trial
This is an interventional treatment trial for Placenta Previa focused on measuring Placenta Previa, Vaginal Pessary, Premature Birth
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)
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
Experimental
No Intervention
Cervical Pessary Placement
Expectant Managment
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.