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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Segment Hysterotomy + Crossed hysterorrhaphy | Active Comparator | 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. |
|
| High Segment Hysterotomy + Crossed hysterorrhaphy | Experimental | 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. |
|
| Low Segment Hysterotomy + Non-Crossed hysterorrhaphy | Experimental | 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. |
|
| High Segment Hysterotomy + Non-Crossed hysterorrhaphy | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low segment hysterotomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 to 16 weeks post-hysterotomy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 to 16 weeks post-hysterotomy |
| Myometrial thickness in the portion immediately cephalad to the residual myometrial defect |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Albaro J. Nieto, M.D. | Contact | 3319090 | 4022 | albaro.nieto@fvl.org.co |
| Name | Affiliation | Role |
|---|---|---|
| Albaro J. Nieto, M.D. | Fundacion Clinica Valle del Lili | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Valle del Lili | Recruiting | Cali | Valle del Cauca Department | 760032 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26849801 | Background | Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016. | |
| 29660186 | Background | Buca D, Liberati M, Cali G, Forlani F, Caisutti C, Flacco ME, Manzoli L, Familiari A, Scambia G, D'Antonio F. Influence of prenatal diagnosis of abnormally invasive placenta on maternal outcome: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Sep;52(3):304-309. doi: 10.1002/uog.19070. Epub 2018 Jul 29. |
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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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| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
|
| High segment hysterotomy | Procedure | A high segment hysterotomy is a surgical procedure involving an incision in the upper segment of the uterus. |
|
| Crossed hysterorrhaphy | Procedure | 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 | Procedure | 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 |
|
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention |
| 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 | 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 | 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 | 6 to 16 weeks post-hysterotomy |
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| D010922 | Placenta Diseases |