A Trial to Reduce Adhesions Following a Primary Cesarean Section

NCT01819467 | Terminated Results

• 1 other identifier: 1301-1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Tissue Adhesions

Outcome Measures

Primary Outcomes (1)

• Adhesion Formation Following a Primary C-section With and Without Adhesion Barrier

  Study was terminated due to too many protocol deviations. There were no outcome measures analyzed.

  21 months

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

Patients in this group will receive Seprafilm onto the uterine incision and the anterior midline of the uterus.

Device: Seprafilm

Control Group

NO INTERVENTION

This arm will be known as the control/no intervention group. This group will not receive Seprafilm or any other adhesion barrier method

Interventions

Seprafilm DEVICE

Seprafilm will be placed onto the uterine incision and the anterior midline of the uterus following the primary cesarean section

Treatment Group

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Females 12 years and older undergoing a scheduled primary cesarean section at or after 24 weeks estimated gestational period

You may not qualify if:

• Patients transferred from outlying hospitals who expect to undergo repeat C-section at that hospital.
• Patients who have had previous laparotomy
• Patients having a previous laparoscopy demonstrating adhesions of bladder peritoneum or uterine serosa or myometrium to the parietal peritoneum or omentum or bowel to the uterus or parietal peritoneum; or involving pelvic adhesiolysis, enterolysis or other surgery on bowel located in the pelvis, uterine myomectomy , adnexectomy or other adnexal surgery including ovarian cystectomy, tuboplasty, tubal reanastomosis, and removal of endometriosis
• Patients with an adhesion score \> 0 at the time of primary cesarean section
• Patents with chorioamnionitis, appendicitis or infection of other pelvic viscera at the time of primary cesarean section.
• Patients who have taken systemic corticosteroids within 2 weeks of the primary cesarean section. Provided however, patients who have been treated with systemic betamethasone or dexamethasone to promote fetal lung maturity are not excluded
• Patients undergoing tubal sterilization at the time of the primary cesarean section
• Patients with known allergy to hyaluronic acid
• The following criteria are seen as complications or adverse events experienced by the patients in the interval after the puerperium and will therefore exclude patients:
• Patient who have had a pelvic inflammatory disease documented by either cervical motion, uterine or adnexal tenderness; and either oral temperature \> 101 degrees or mucopurulent cervical discharge or cervical culture positive for C. trachomatis or N. Gonorrhoeae
• Patients who have pelvic abscess or diverticulitis

Sponsors & Collaborators

• South East Area Health Education Center, Wilmington, NC: lead
• New Hanover Regional Medical Center: collaborator

Study Sites (1)

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Related Publications (2)

• Morales KJ, Gordon MC, Bates GW Jr. Postcesarean delivery adhesions associated with delayed delivery of infant. Am J Obstet Gynecol. 2007 May;196(5):461.e1-6. doi: 10.1016/j.ajog.2006.12.017.

  PMID: 17466702 BACKGROUND

• Lyell DJ. Adhesions and perioperative complications of repeat cesarean delivery. Am J Obstet Gynecol. 2011 Dec;205(6 Suppl):S11-8. doi: 10.1016/j.ajog.2011.09.029. Epub 2011 Oct 6.

  PMID: 22114993 BACKGROUND

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Henry Easley
• Organization: NHRMC

sandy.easley@seahec.net

910. 667-9238

Study Officials

• Henry A Easley, MD

  South East Area Health Education Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair/Program Director of Residency Program Department of Obstetrics & Gynecology NH NHRMC

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 27, 2013
• Study Start: June 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 16, 2023
• Results First Posted: August 16, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)