Placenta Accreta Spectrum
Conditions
Keywords
High segmental hysterotomy, Low segmental hysterotomy, Caesarean section, hysterotomy defects
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.
Interventions
PROCEDURELow segment hysterotomy
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.
PROCEDUREHigh segment hysterotomy
A high segment hysterotomy is a surgical procedure involving an incision in the upper segment of the uterus.
PROCEDURECrossed hysterorrhaphy
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.
PROCEDURENon-Crossed hysterorrhaphy
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
Sponsors
Fundacion Clinica Valle del Lili
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women aged ≥ 18 years. * Confirmed pregnancy through clinical history or ultrasound between 36 and 42 weeks of gestation. * Indication by the attending gynecologist for a first cesarean section, either emergent or elective.
Exclusion criteria
* History of myometrial intervention, such as myomectomy. * History of genetic or acquired conditions that alter the anatomy of the uterus. * History of coagulation disorders. * History of connective tissue disorders, such as Lupus and Scleroderma, which may affect healing. * Hemodynamically unstable patients due to a clinical condition prior to performing the cesarean section. * Failure to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of uterine wall defect at the scar site | 6 to 16 weeks post-hysterotomy | Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual myometrial thickness of the uterine wall defect at the scar site | 6 to 16 weeks post-hysterotomy | Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention |
| Myometrial thickness in the portion immediately cephalad to the residual myometrial defect | 6 to 16 weeks post-hysterotomy | Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention |
| Myometrial thickness in the portion immediately caudal to the residual myometrial defect | 6 to 16 weeks post-hysterotomy | Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention |
| Size of the uterine wall defect | 6 to 16 weeks post-hysterotomy | Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention |
| Depth of the defect in the uterine wall | 6 to 16 weeks post-hysterotomy | Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention |
Countries
Colombia
Contacts
CONTACTAlbaro J. Nieto, M.D.
PRINCIPAL_INVESTIGATORAlbaro J. Nieto, M.D.
Fundacion Clinica Valle del Lili
Outcome results
None listed