Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620432
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
High Vs Low Segmental Hysterotomy Impact on Uterine Wall Defects Post-Cesarean
Sponsor:
None
Organization:
None
Study Overview
Official Title:
High Segmental Hysterotomy Vs Low Segmental Hysterotomy Association with the Incidence of Uterine Wall Defects After Cesarean Section
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HISEAL
Brief Summary:
The purpose of this clinical trial is to compare the incidence of defects in the uterine wall at the site of the scar niche and surgical complications when using high-segment versus low-segment hysterotomy with both cross-suturing and non-cross-suturing techniques in pregnant patients undergoing their first cesarean section
Researchers will compare four arms
Low Segment Hysterotomy Crossed hysterorrhaphy
High Segment Hysterotomy Crossed hysterorrhaphy
Low Segment Hysterotomy Non-Crossed hysterorrhaphy
High Segment Hysterotomy Non-Crossed hysterorrhaphy
Participants will
Cesarean delivery
Attend a follow up appointment between 6 to 16 weeks post surgery where will be perform a transvaginal sonography
Researchers will compare four arms
Low Segment Hysterotomy Crossed hysterorrhaphy
High Segment Hysterotomy Crossed hysterorrhaphy
Low Segment Hysterotomy Non-Crossed hysterorrhaphy
High Segment Hysterotomy Non-Crossed hysterorrhaphy
Participants will
Cesarean delivery
Attend a follow up appointment between 6 to 16 weeks post surgery where will be perform a transvaginal sonography
Detailed Description:
This study will be conducted as a single-blind trial Patients will be approached in the delivery room where a comprehensive review of the inclusion and exclusion criteria checklist will be conducted to determine their eligibility for the study Once eligible patients are identified the study will be thoroughly explained to them highlighting its purpose potential benefits and risks This will be followed by a detailed discussion of the informed consent form to ensure that participants fully understand what their involvement entails
Upon obtaining informed consent a randomization process will be implemented to allocate participants to one of the four study arms The assigned procedure will be performed by their attending gynecologist who is familiar with their medical history and care needs Throughout the study various outcomes will be measured including intraoperative findings postoperative recovery and post-discharge progress
A transvaginal pelvic ultrasound will be ordered to be performed between 6 and 16 weeks postoperatively During the single follow-up appointment this imaging evaluation will be carried out to determine the presence or absence of an isthmocele as well as to assess its characteristics such as size and location if present
Upon obtaining informed consent a randomization process will be implemented to allocate participants to one of the four study arms The assigned procedure will be performed by their attending gynecologist who is familiar with their medical history and care needs Throughout the study various outcomes will be measured including intraoperative findings postoperative recovery and post-discharge progress
A transvaginal pelvic ultrasound will be ordered to be performed between 6 and 16 weeks postoperatively During the single follow-up appointment this imaging evaluation will be carried out to determine the presence or absence of an isthmocele as well as to assess its characteristics such as size and location if present
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None