Clinical trial NCT01996345: Vaginal Pessary Versus Expectant Management for Placenta Previa
Official title: Vaginal Pessary Versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women With Placenta Previa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Placenta Previa
Keywords: Placenta Previa
Vaginal Pessary
Premature Birth
Lead sponsor: Pediatrix
Sponsor class: OTHER
Collaborators: name: Obstetrix Medical Group
First posted: 2013-11-27
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Decrease Delivery Prior to 36 weeks in patients with a gestational age of 22.0- 32.0 presenting with placenta previa.
timeFrame: day of birth
Secondary outcomes:
measure: Need for packed red blood cells or hematologic product replacement
timeFrame: from birth to 60 days
measure: Neonate or Fetal Death
timeFrame: From time of trial entry to 60 days post birth (approximately 34 weeks)
measure: Neonatal Outcomes
timeFrame: From Birth to 60 days of Age
measure: Any adverse reactions to the cervical pessary.
timeFrame: from 0 to as many as 18 weeks.
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Denver
country: United States
facility: Presbyterian/St Luke's Hospital
state: Colorado
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Louisville
country: United States
facility: Norton Kosair Children's Hospital
state: Kentucky
city: Metairie
country: United States
facility: Tulane - Lakeside Hospital for Women and Children
state: Louisiana
city: New Orleans
country: United States
facility: Touro Infirmary
state: Louisiana
city: Houston
country: United States
facility: Baylor/Texas Children's Hospital & Pavilion
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Obstetrix Medical Group
name: Thomas Garite, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Irene Stafford, MD
role: PRINCIPAL_INVESTIGATOR
References: