Clinical Trial: Vaginal Pessary Versus Expectant Management for Placenta Previa

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Vaginal Pessary Versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women With Placenta Previa

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 Summary:

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.


Sponsor: Obstetrix Medical Group

Current Primary Outcome: Decrease Delivery Prior to 36 weeks in patients with a gestational age of 22.0- 32.0 presenting with placenta previa. [ Time Frame: day of birth ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Need for packed red blood cells or hematologic product replacement [ Time Frame: from birth to 60 days ]
    note the number of blood transfusions the baby received from birth until 60 days post birth
  • Neonate or Fetal Death [ Time Frame: From time of trial entry to 60 days post birth (approximately 34 weeks) ]
  • Neonatal Outcomes [ Time Frame: From Birth to 60 days of Age ]
    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.
  • Any adverse reactions to the cervical pessary. [ Time Frame: from 0 to as many as 18 weeks. ]


Original Secondary Outcome: Same as current

Information By: Mednax Center for Research, Education and Quality

Dates:
Date Received: November 14, 2013
Date Started: October 2016
Date Completion: December 2020
Last Updated: January 18, 2017
Last Verified: January 2017