NCT03026647

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

January 31, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

January 18, 2017

Last Update Submit

November 8, 2017

Conditions

Cesarean Section; Complications, Wound, Hematoma

Outcome Measures

Primary Outcomes (1)

  • Preferred suture

    Preferred suture chart review

    3 months

Interventions

SuturePROCEDURE

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.

Eligibility Criteria

Age14 Years - 55 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female, pregnant, All ethnic backgrounds,

You may qualify if:

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

You may not qualify if:

  • unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesHematoma

Interventions

Sutures

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Jennifer Goldkamp, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 20, 2017

Study Start

January 31, 2017

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

November 13, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)