A Pilot-study to determine the (cost)effectiveness of the adhesion barrier 4DryField® PH in prevention of dysmenorrhea, pain and niche-related problems after Caesarean sections

The increasing CS rate has stimulated an interest in the potential long term morbidity of CS scar, such as uterine rupture or malplacentation. Other less severe, but more prevalent long term symptoms are gynecological symptoms and subfertility. There is a strong association between a niche and these complains. A niche (sometimes called a caesarean scar defect) is defined as a defect in the myometrium of at least 2mm at the site of the uterine CS scar and was observed in 50 to 60% of the patients after a CS. Apart from niche formation, development of adhesions is another complication of a CS, which possibly contributes to female subfertility, pelvic pain, complications in surgeries and spotting. The hypothesis is that adhesions may induce niche development due to retraction of the scar tissue, which pulls on the uterine scar towards the abdominal wall. To prevent these retractile forces, the barrier agent 4DryField® can to be used. 4DryField® is a powder which is transformed into a viscous gel. The gel functions as a temporary mechanical barrier separating surgically traumatized tissue and ensuring the healing of the respective surfaces. It is already used in daily practice and was shown to be efficient in prevention of adhesion formation in gynecological surgery as well as general surgery and animal models although no publication is available describing its effects after a CS.

4DryField® PH on the uterine wound reduces adhesions between the uterus and bladder/abdominal wall and as a consequence reduction of dysmenorrhea, pelvic pain and niche related problems after caesarean sections.

Dysmenorrhea at 3 and 9 months after the CS, measured on a NRS from 0 to 10 is the main parameter, on which the sample size is also calculated. The study endpoint will be the 3-year follow-up evaluating fertility, niche related symptoms and medical consultation.

Subjects will receive treatment with the investigational product 4DryField® PH after closure of the uterus. The powder is applied directly onto the uterine scar and then transformed into a gel through dripping with isotonic 0.9% sodium chloride solution.