Suture Material for Closure of Hysterotomy

Cesarean Section; Complications, Wound, Hematoma Clinical Trial

Official title:

Evaluation of Suture Material for Closure of Hysterotomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03026647
• Other study ID #: 27509
• Status: Withdrawn
• Phase: N/A
• First received: January 18, 2017
• Last updated: November 8, 2017
• Start date: January 31, 2017
• Est. completion date: May 2018

Study information

• Verified date: November 2017
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective chart review evaluating different suture types on surgical outcomes for cesarean delivery and vaginal birth after cesarean delivery outcomes when different sutures are used.

Description:

Cesarean sections are one of the most common surgeries performed in the United States; approximately 1 out of 3 births are completed by cesarean delivery. In 2014, 1,284,551 cesarean deliveries were performed. Unfortunately, even with this being a very common procedure some surgical topics have not been fully evaluated. One of these topics is the choice of suture for repair of the hysterotomy (uterine) incision. Several suture materials are available, yet only polygatactin-910 and catgut have been evaluated in a single study. In this study, only surgery complications were evaluated. Catgut was found to be associated with less risk of receiving a blood transfusion, otherwise no differences were found. One of the most common suture materials used at our institution is poliglecaprone 25, however no long term studies have been completed for this indication. In addition, no studies have evaluated the risk of uterine rupture with trial of labor after cesarean after using poliglecaprone 25 to repair the hysterotomy. This information could be very useful in counseling for patients. As the cesarean delivery rates continue to climb, information on appropriate technique for surgery are needed.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Gender: Female
• Age group: 14 Years to 55 Years

Eligibility

Inclusion Criteria:

• Pregnant women who underwent a cesarean delivery or vaginal birth after cesarean

Exclusion Criteria:

• unable to give consent

Related Conditions & MeSH terms

• Cesarean Section; Complications, Wound, Hematoma
• Hematoma

Intervention

Procedure:
• Suture
To examine different types of suture material used for hysterotomy closure in cesarean section and determine if one is preferred above other types due to a complications profile.

Locations

Country	Name	City	State
United States	St. Mary's Health Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preferred suture	Preferred suture chart review	3 months