Cesarean Section; Complications, Wound, HematomaNCT03026647
Suture Material for Closure of Hysterotomy
An observational study of Cesarean Section; Complications, Wound, Hematoma, run by St. Louis University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 55 years, women only
- Conditions the study is for
- Cesarean Section; Complications, Wound, Hematoma
- What is being tested?
- Suture
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2017to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- Women only
- Child, Adult
Study population: Female, pregnant, All ethnic backgrounds,
Who may be able to join
- Pregnant women who underwent a cesarean delivery or vaginal birth after cesarean
Who cannot join
- unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Suture
- Medical subject headings
- Wounds and Injuries, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutureProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferred suture
Preferred suture chart review
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start31 Jan 2017
- Primary completionApr 2018 (estimated)
- Study completionMay 2018 (estimated)
Why it stopped: Not moving forward staff shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; Complications, Wound, HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Goldkamp, MD, St. Louis University
- Investigators
- Jennifer Goldkamp, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026647
- Sponsor's protocol ID
- 27509
- Status last verified
- Nov 2017
- First submitted
- 18 Jan 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Suture Material for Closure of Hysterotomy
- ClinicalTrials.gov ID
- NCT03026647
- Acronym / sponsor ID
- 27509
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not moving forward staff shortage
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 55 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Female, pregnant, All ethnic backgrounds,
Key inclusion criteria (1 listed)
- Pregnant women who underwent a cesarean delivery or vaginal birth after cesarean
Key exclusion criteria (1 listed)
- unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SutureTo 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. | Procedure or surgery | – |
Primary outcome
Preferred suture
Time frame: 3 months
Preferred suture chart review
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Goldkamp, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section; Complications, Wound, Hematoma, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preferred suture (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.