High vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean

Official title

High Segmental Hysterotomy vs. Low Segmental Hysterotomy: Association With the Incidence of Uterine Wall Defects After Cesarean Section

Overview

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

• Procedure Low 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.
• Procedure High segment hysterotomy
  A high segment hysterotomy is a surgical procedure involving an incision in the upper segment of the uterus.
• Procedure Crossed 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.
• Procedure Non-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

Primary outcome measures

• Incidence of uterine wall defect at the scar site [Time frame: 6 to 16 weeks post-hysterotomy]

Secondary outcome measures (5)

• Residual myometrial thickness of the uterine wall defect at the scar site [Time frame: 6 to 16 weeks post-hysterotomy]
• Myometrial thickness in the portion immediately cephalad to the residual myometrial defect [Time frame: 6 to 16 weeks post-hysterotomy]
• Myometrial thickness in the portion immediately caudal to the residual myometrial defect [Time frame: 6 to 16 weeks post-hysterotomy]
• Size of the uterine wall defect [Time frame: 6 to 16 weeks post-hysterotomy]
• Depth of the defect in the uterine wall [Time frame: 6 to 16 weeks post-hysterotomy]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Colombia · 1 center

• Fundación Valle del Lili — Cali

Publications

• 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. PMID 26849801
• 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. PMID 29660186
• Silver RM, Fox KA, Barton JR, Abuhamad AZ, Simhan H, Huls CK, Belfort MA, Wright JD. Center of excellence for placenta accreta. Am J Obstet Gynecol. 2015 May;212(5):561-8. doi: 10.1016/j.ajog.2014.11.018. Epub 2014 Nov 20. PMID 25460838
• Palacios-Jaraquemada JM. Placental adhesive disorders, 1st ed. Berlin: DeGruyter editors, 2012 161 pages. ISBN 978-3-11-028238-2.
• Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24. PMID 28599899
• Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25. PMID 26409016
• Fabres C, Aviles G, De La Jara C, Escalona J, Munoz JF, Mackenna A, Fernandez C, Zegers-Hochschild F, Fernandez E. The cesarean delivery scar pouch: clinical implications and diagnostic correlation between transvaginal sonography and hysteroscopy. J Ultrasound Med. 2003 Jul;22(7):695-700; quiz 701-2. doi: 10.7863/jum.2003.22.7.695. PMID 12862268
• Kremer TG, Ghiorzi IB, Dibi RP. Isthmocele: an overview of diagnosis and treatment. Rev Assoc Med Bras (1992). 2019 Jun 3;65(5):714-721. doi: 10.1590/1806-9282.65.5.714. PMID 31166450

Identifiers

NCT: NCT06620432 · 2024.079

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗