An interventional study of Low segment hysterotomy and High segment hysterotomy in Placenta Accreta Spectrum, sponsored by Fundacion Clinica Valle del Lili. Recruiting at 1 site in Colombia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Fundacion Clinica Valle del Lili · Not applicable, Interventional, and Prevention
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:
Participants will:
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.
150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.
This study's planned enrollment of 168 is above the median of 70 across 67 interventional studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Fundacion Clinica Valle del Lili is the lead sponsor of 25 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
Procedure: Low segment hysterotomy · Procedure: Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
Procedure: High segment hysterotomy · Procedure: Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
Procedure: Low segment hysterotomy · Procedure: Non-Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
Procedure: High segment hysterotomy · Procedure: Non-Crossed hysterorrhaphy
A low segment hysterotomy is a surgical procedure in which an incision is made in the lower segment of the uterus, typically during a cesarean section or other uterine surgeries. This approach is preferred because the lower uterine segment is thinner and less vascular, reducing the risk of bleeding and complications during and after the procedure. The incision is typically horizontal.
A high segment hysterotomy is a surgical procedure involving an incision in the upper segment of the uterus.
Crossed hysterorrhaphy is a surgical technique used to close the uterine incision following a hysterotomy, particularly during cesarean sections. In this method, the sutures are placed in a crossed or X-shaped pattern, which helps to evenly distribute tension across the incision site.
Non-crossed hysterorrhaphy is a surgical technique used to close a uterine incision, typically after a hysterotomy, such as during a cesarean section. In this method, the sutures are placed in a linear, parallel fashion rather than in a crossed or X-shaped pattern
Incidence of uterine wall defect at the scar site
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Time frame: 6 to 16 weeks post-hysterotomy
Residual myometrial thickness of the uterine wall defect at the scar site
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Time frame: 6 to 16 weeks post-hysterotomy
Myometrial thickness in the portion immediately cephalad to the residual myometrial defect
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Time frame: 6 to 16 weeks post-hysterotomy
Myometrial thickness in the portion immediately caudal to the residual myometrial defect
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Time frame: 6 to 16 weeks post-hysterotomy
Size of the uterine wall defect
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Time frame: 6 to 16 weeks post-hysterotomy
Depth of the defect in the uterine wall
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
Time frame: 6 to 16 weeks post-hysterotomy
Plan to share: No — No individual participant data (IPD) will be shared, as disclosure of information related to the medical history of participants or health care workers is not permitted under applicable regulations.
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