The insertion of a simple non-invasive cervical pessary during the second trimester of pregnancy in women at high risk of preterm delivery (those with a short cervix) significantly reduces the probability of early delivery, the main cause of mortality or serious subsequent illness in the newborn. This is demonstrated by the randomized scientific trial conducted by Vall d'Hebron and published in the online edition of the medical journal The Lancet.

The pessary is a simple silicone ring, low cost (38 euros), non-invasive and easy to insert and remove, which is inserted vaginally around the cervix without surgical intervention. Ninety-five percent of the women who have worn it would recommend it to other at-risk pregnant women because it has no serious side effects. 

The study led by the Vall d'Hebron University Hospital and the Vall d'Hebron Research Institute (VHIR) has had the collaboration of five other Spanish hospitals that have provided a significant sample of 380 pregnant women who were found (in an ultrasound scan performed at 22 weeks of gestation) to have a short cervix, i.e. a cervical length of 25 mm. This is one of the main risk factors for prematurity. Half of those women, chosen at random, used the cervical pessary and the other half did the usual treatment and medical follow-up without the pessary.

The study showed a significant reduction in preterm delivery (almost 30% among women with pessary compared to only a 6% reduction among women without pessary) before 34 weeks of gestation.

It should be remembered that preterm delivery is one of the most important problems in perinatology today and one of the most common causes of illness and/or mortality in newborns. Prematurity is, for example, the main cause of death in the first month of life, such that a premature baby is 180 times more likely to die than a fetus that has been able to complete the entire gestation period.

While it is true that technological and medical advances have made possible an increase in the survival of very low birth weight infants, it is no less true that prematurity rates have remained almost unchanged in recent years. Moreover, the complications associated with premature babies remain unchanged despite medical advances: learning difficulties, cerebral palsy, blindness... among other respiratory, visual, auditory, neurological, cognitive or behavioral sequelae that often affect the newborn for life.

Dr. Elena Carreras, head of the Maternal-Fetal Medicine Unit of the Obstetrics Department of the Vall d'Hebron University Hospital and coordinator of the study, stated that "finding a safe and economical method to reduce the incidence of preterm birth and reduce the burden of prematurity and its sequelae is an objective worth working for. The results of our study open the door to further research on the use of this device and give us hope that it is possible to find a way to substantially reduce prematurity in the world."

Dr. María Goya, gynecologist of the same Unit and principal investigator, affirms that: "the placement of the pessary is an economical, safe and reliable alternative for the prevention of premature birth in the population at greatest risk, that of pregnant women with a short cervix".

In this same project, called PECEP, which has received funding from the FIS 07/1086 project of the Instituto de Salud Carlos III through the cooperation of the Vall d'Hebron Institut de Recerca (VHIR), the same working group has described and validated a new technique for measuring the cervix, since the classic technique did not allow correct visualization of the cervix of pregnant women with a pessary. The same working group is currently leading four other clinical trials on cervical pessaries. The first includes a population of twins of mothers with short cervix (PECEP-TWINS); the second and third, a group of patients presenting short cervix between 24 and 34 weeks of gestation, both in single gestations (PECEP-RETARD) and in twin gestations (PECEP-RETARD-TWINS), and the fourth, a group of patients with singleton gestations and feto-fetal transfusion syndrome among twins who have undergone prenatal surgery (PECEP-LASER).

Finally, it is also relevant to say that the cervical pessary is manufactured by a German non-profit foundation, the Clara-Angela-Foundation, headed by Dr. Birgit Arabin, which in 2003 already carried out the first (non-randomized) studies on its benefits and decided to manufacture it in a production that provides jobs for the mentally and physically handicapped and that, therefore, does not have the support of the large pharmaceutical industry. For this reason - and because of the simplicity of the ring - the price of the pessary does not reach 40 euros; almost nothing, if compared to the savings for the health system that would represent a reduction in premature birth, its first neonatal care and the corresponding medical complications.

According to data provided by the same journal, The Lancet, to contextualize the impact that this study could have, "worldwide, it is estimated that some 13 million babies are born prematurely every year (before 37 weeks of pregnancy). Preterm birth then costs the health care system, in the USA alone, more than 26 million dollars/year".