Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT06620432
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.
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.
Study:
NCT06620432
Study Brief:
Protocol Section:
NCT06620432