Placenta Previa Clinical Trial
Official title:
Vaginal Pessary Versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women With Placenta Previa
NCT number | NCT01996345 |
Other study ID # | OBX0028 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | September 5, 2018 |
Verified date | September 2018 |
Source | Mednax Center for Research, Education, Quality and Safety |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 17 |
Est. completion date | September 5, 2018 |
Est. primary completion date | September 5, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 54 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Denver Health and Hospital Authority | Denver | Colorado |
United States | Presbyterian/St Luke's Hospital | Denver | Colorado |
United States | Baylor/Texas Children's Hospital & Pavilion | Houston | Texas |
United States | Long Beach Memorial Medical Center | Long Beach | California |
United States | Norton Kosair Children's Hospital | Louisville | Kentucky |
United States | Tulane - Lakeside Hospital for Women and Children | Metairie | Louisiana |
United States | University of South Alabama Medical Center | Mobile | Alabama |
United States | Touro Infirmary | New Orleans | Louisiana |
United States | Good Samaritan Hospital | San Jose | California |
United States | Swedish Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Mednax Center for Research, Education, Quality and Safety | Obstetrix Medical Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Need for packed red blood cells or hematologic product replacement | note the number of blood transfusions the baby received from birth until 60 days post birth | from birth to 60 days | |
Secondary | Neonate or Fetal Death | death of fetus or newborn up to 60 days post delivery | From time of trial entry to 60 days post birth (approximately 34 weeks) | |
Secondary | Neonatal Outcomes | 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. | From Birth to 60 days of Age | |
Secondary | Any adverse reactions to the cervical pessary. | unexpected adverse reaction such as cervical trauma, infection, allergy | from 0 to as many as 18 weeks. |
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