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NCT Number: NCT06620432

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

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.

Recruiting

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Key information

Conditions

Placenta Accreta Spectrum Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Accreta Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fundación Valle del Lili

Cali, Valle del Cauca Department, 760032, Colombia

Location status: Recruiting

Location contact

Albaro J. Nieto, M.D. PhD

CONTACT

[email protected]

3319090 ext. 4022

José M. Palacios, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Incidence of uterine wall defect at the scar site

    Time frame: 6 to 16 weeks post-hysterotomy

    Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention

Secondary outcomes

  1. Residual myometrial thickness of the uterine wall defect at the scar site

    Time frame: 6 to 16 weeks post-hysterotomy

    Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention

  2. Myometrial thickness in the portion immediately cephalad to the residual myometrial defect

    Time frame: 6 to 16 weeks post-hysterotomy

    Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention

  3. Myometrial thickness in the portion immediately caudal to the residual myometrial defect

    Time frame: 6 to 16 weeks post-hysterotomy

    Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention

  4. Size of the uterine wall defect

    Time frame: 6 to 16 weeks post-hysterotomy

    Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention

  5. Depth of the defect in the uterine wall

    Time frame: 6 to 16 weeks post-hysterotomy

    Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Albaro J. Nieto, M.D.

CONTACT

[email protected]

3319090 ext. 4022

Sponsors and collaborators

Lead sponsor

Fundacion Clinica Valle del Lili

Other

Registry information

Official study title

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

Acronym: HISEAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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