Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT01819467
Brief Summary:
The primary objective of this study is to determine whether the use of Seprafilm reduces the incidence rate of adhesion formation following a primary C-section.
A secondary objective of the study will be to determine whether or not a correlation between the adhesion score and the difficulty or delay in delivery of the infant exists.
Detailed Description:
A cesarean section or delivery (C-section/CD) is the surgical removal of an infant and placenta through the mother's abdominal and uterine wall. This procedure is performed by an obstetrician and is one of the most common types of surgical methods used today. According to the Centers for Disease Control and Prevention, the rate for this method of delivery has risen over the past decade. However, recent research has shown that patients who receive this surgical procedure become more susceptible to adhesions.
Adhesions are formations (bands) of scar tissue that occur immediately following most surgical procedures. Adhesions limit the mobility of tissues and organs near the incision site by causing them to stick together. This limited mobility can generate an increased rate of morbidity (occurrence of other diseases). Morbidities caused by adhesions include but are not limited to abdominal and/or pelvic pain, bowel obstruction (partial or complete blockage of the bowel), subfertility (difficulty getting pregnant) and infertility (inability to get pregnant).
A study conducted by Dierdre Lyell, MD reported that the incidence of adhesion formation following a primary CD ranges from 46-65%. Another study (Morales et al) reported that for women who had undergone a CD, the incidence rate of adhesions and severe adhesions was greater in women who had had repeat CDs compared with women who only had a primary CD. In addition, this study also states that the percentage of adhesion occurrence increases in women with each subsequent (following) CD.
Numerous methods have been implemented toward the preventions of adhesions. Currently, Seprafilm is an approved adhesion prevention method that is used in most surgical procedures. Seprafilm is a clear film that is composed of chemically modified sugars (some of which occur naturally in the human body). Unlike its counterpart Interceed, Seprafilm is unaffected by the presence of blood. After being placed, Seprafilm becomes a gel within 24-48 hours and then is slowly absorbed and excreted by the body over the course of 1-4 weeks.
Seprafilm Adhesion Barrier is FDA approved for use in patients undergoing abdominal or pelvis laparotomy as an adjunct intended to reduce the incidence, extent and severity of post-operative adhesions between the abdominal and between the uterus and surrounding structures.
Study:
NCT01819467
Study Brief:
Protocol Section:
NCT01819467