Public Release: 

Safe, low-cost device could prevent premature delivery in women at high risk of preterm birth

Lancet

Insertion of a safe, low-cost cervical pessary during the midtrimester of pregnancy in women who are at a high risk for preterm birth (those with a short cervix) significantly reduces the likelihood of premature delivery, the leading cause of death in newborns. The findings of the first randomised trial to investigate the use of a pessary to prevent premature birth are published Online First in The Lancet.

"Finding a safe, economical way (38 euros per pessary) of reducing the incidence of preterm birth in the world and reducing the burden of prematurity and its sequelae is a worthwhile goal", explains Elena Carreras from the Hospital Universitari Vall d'Hebron, Barcelona, Spain, coordinator of the study. "Our results open the door to further research into the use of this device and give us hope of finding a way to substantially reduce the incidence of prematurity and its consequences worldwide."

Worldwide, an estimated 13 million babies are born prematurely (before they reach 37 weeks of pregnancy) every year. Spontaneous preterm birth is the leading cause of illness and death in newborns and can also result in lifelong health problems including learning difficulties, cerebral palsy, blindness, and breathing problems. According to the Institute of Medicine, preterm birth costs the USA more than $26 billion each year. But despite efforts to reduce the rates of preterm birth, little progress has been made over the past 10 years.

The PECEP trial recruited nearly 15 000 pregnant women undergoing a routine midtrimester ultrasound from five hospitals in Spain who agreed to have a cervical length assessment. Women with a cervical length of less than 25mm (a short cervix is a major risk factor for preterm birth) were randomly assigned to a cervical pessary (190 women) or expectant management without a pessary (190).

Women who had a pessary were significantly less likely to give birth prematurely, defined in this study as birth before 34 weeks of pregnancy (6% pessary group vs 27% expectant management group).

No serious side effects were reported with the pessary and women in the pessary group experienced a significantly reduced rate of low birthweight (less than 2500 g), respiratory difficulties, and treatment for sepsis.

Additionally, a satisfaction questionnaire reported that 95% of the women given a pessary said they would recommend this intervention to others.

Maria Goya, principal investigator of the study says: "Placement of a pessary is an affordable procedure, non-invasive, and easy to insert and remove as required."

The authors conclude: "The pessary is an affordable, safe, and reliable alternative for prevention of preterm birth in a population of appropriately selected at-risk pregnant women who have been screened for cervical length assessment at the midtrimester scan."

In a Comment, Steve Caritis and Hyagriv Simhan from Magee Women's Hospital, Pittsburgh, USA say: "The findings...raise the novel and exciting possibility that the anatomic inter-relationship of pelvic organs and their load-bearing capacity are important in pregnancy maintenance...Additional well designed studies, however, are needed before pessary use can be validated as an effective treatment for women with precocious cervical ripening."

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Dr Maria Goya and Dr Elena Carreras, Maternal Fetal Medicine Unit, Department of Obstetrics, Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona, Spain. T) +34 934893085 E) mgoya@vhebron.net or ecarreras@vhebron.net

Dr Steve Caritis, Magee Women's Hospital, Pittsburgh, USA. T) +1 412 641 5256 E) scaritis@mail.mgee.edu

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