NCT03041220

Brief Summary

Retrospective chart review using both out patient and inpatient records of obese patients (BMI of 30 or greater) who have had a cesarean section since the year 2009. We will evaluate the patient's BMI, their skin incision type at time of c-section, their co-morbidities, number of previous c-sections and post partum follow up for wound infection, wound separation and wound breakdown. We will also review operative notes to evaluate blood loss, length of surgery and complications during surgery. We will obtain maternal characteristics and information about the pregnancy.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2016

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

January 11, 2017

Last Update Submit

August 9, 2023

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • Type of skin incision

    Identify which type of skin incision has better outcomes in obese pregnant patients

    Delivery to 6 weeks postpartum

Study Arms (1)

cesarean section

Obese pregnant patients who have had a cesarean section.

Procedure: cesarean section

Interventions

cesarean sectionPROCEDURE

obese patients (BMI of 30 or greater) who have had a cesarean section

cesarean section

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Ages between 18 - 45 years, female, and no limitation on ethnic background.

You may qualify if:

  • obese patients (BMI of 30 or greater) who have had a cesarean section

You may not qualify if:

  • Vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Heather Said, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

February 2, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share