Risk Factors

Preterm Birth is a growing, global human healthcare crisis and is the leading cause of infant death and morbidity within the first month of life, while also recognized as one of the most significant contributing factors to a number of lifelong crippling diseases including autism, cerebral palsy, blindness, deafness, various respiratory ailments, and more.

Our Cervical Stabilization Device will be cost effective to manufacture, promises a low risk treatment (accessible even to patients in the most remote and underdeveloped regions of the world), and addresses conditions including:

Incompetent cervix
Known cases of organ and tissue compromise
Pregnancies involving multiple fetuses

Late / Early life pregnancy
Disease (including Chorioamnionitis and others)
Fetal related conditions (such as Polyhydramnios)

Click headings for more or less information.

More on Incidences and Causes:

10% to 12% of all labors begin when the amniotic sac, also known as the ‘bag of water’ “BOW” ruptures (in about 95% of cases leading to labor within 24 hours); whether the pregnancy is full term or otherwise (why CSD should be utilized at the earliest indication of an ‘at risk’ pregnancy).

The BOW may rupture prematurely when challenged by multiple fetuses (two or more) which involves a growing patient population as fertility treatments are on the rise. (It is the author’s opinion that the use of CSD should become a ‘standard of care’ practice, as multiple fetus pregnancies develop to a total combined fetal weight proximate that of a single fetus average weight at any period of time during the pregnancy.)

The BOW may also rupture prematurely as a consequence of poor nutrition, which can weaken the membranes and also increase the risk of infection. This is a crucial consideration in underdeveloped regions where the greatest population of at risk patients resides.

A ‘loose’ or Incompetent Cervix “IC”, as previously addressed (and a driving factor to the development of CSD), is estimated to be a factor in up to 8% of all cases of PTB. Moreover, the incidence of IC is on the rise as diagnostic procedures such as cervical cone biopsy are increasing.

Chorioamnionitis (an infection of the membranes) results from a variety of organisms which weaken the membranes. (Other than CSD, the author is not aware of any treatment for this preexisting maternal condition at an advanced stage that addresses the risk of PROM or PTB).

Polyhydramnios (too much amniotic fluid), overtaxes the membranes’ properties such that as the fetus grows in weight PROM becomes a significant risk (also a ‘discoverable condition’, that the author believes when treated by CSD will likely prevent PROM and PTB).

Additional Considerations:

Overall infant mortality from PROM is 5%, with infection being the biggest cause of death (morbidity numbers are yet to be verified).

The patient’s own defense to infection is to continually replace the amniotic fluid, which with the down and outward flow discourages bacteria from moving upward (a primary design consideration to CSD, in part addressed by the CSD line-of-sight, natural aeration and drainage tube).

Special Considerations for PROM (prior to 37 weeks gestation):

Infant mortality from PROM for PTB infants is 30%; again, with infection being the biggest cause of death (this 30% amounting to infants from 28 to 37 weeks gestation whose mother’s membranes ruptured before the onset of labor).

Respiratory distress syndrome, resulting from the infant’s lungs being underdeveloped, represents a greater risk than infection resulting from PROM (why every week / day counts in extending the delivery date, and why CSD should be utilized at the very first sign of an at risk pregnancy).

30% of all PTB infants are born breech / malpresentation (other than head down). This further supports our thesis that reducing ‘focused pressure’ upon the BOW is an important feature to the overall function of CSD.