Suture Material for Closure of Hysterotomy

Evaluation of Suture Material for Closure of Hysterotomy

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.

Study Overview

• Status: Withdrawn
• Conditions: Cesarean Section; Complications, Wound, Hematoma
• Intervention / Treatment: Procedure: Suture

Detailed 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • St. Mary's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female, pregnant, All ethnic backgrounds,

Description

Inclusion Criteria:

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

Exclusion Criteria:

• unable to give consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preferred suture	Preferred suture chart review	3 months

Collaborators and Investigators

• Sponsor: St. Louis University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2017
• Primary Completion (ANTICIPATED): April 1, 2018
• Study Completion (ANTICIPATED): May 1, 2018

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (ESTIMATE): January 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hematoma
• Other Study ID Numbers: 27509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No