Intracervical elastomeric sealant in an ex vivo model

Abstract

Background

Premature rupture of membranes occurring in previable midtrimester patients is associated with perinatal mortality, and optimal therapeutic methods are yet to be established.

Objective

This study’s objective was to investigate whether an elastomeric sealant, which has been used as a hemostatic agent for arterial anastomosis, could plug the uterine endocervical canal to prevent leakage of intrauterine fluid in an ex vivo model.

Methods

The elastomeric sealant or fibrin glue was applied to the cervix of uteri removed for benign gynecological disease (n = 4). Normal saline was administered into the ex vivo uterine cavity through a catheter using a pressure infusion bag. Intrauterine pressure was measured using a digital pressure gauge, and the pressure at which normal saline started leaking out of the uterine cervix was compared between both the sealants.

Results

No fluid leakage was observed with the elastomeric sealant until the pressure exceeded 20 kPa (150 mmHg), while the leakage onset pressure with fibrin sealant was 6.6 ± 1.8 kPa (50 ± 14 mmHg). The threshold leak pressure where the onset of liquid flow was initiated was significantly different between both the sealants (p < .0001).

Conclusions

Intracervical elastomeric sealant exhibited powerful fluid leakage prevention in an ex vivo model. The sealant would have potential to prevent the leakage of amniotic fluid in pregnancies with previable premature rupture of membranes.

Keywords:

• Elastomeric sealant
• fibrin glue
• fluid leakage
• premature rupture of membranes
• uterine cervix

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This study was funded by Sanyo Chemical Industries Ltd and Japan Agency for Medical Research and Development.