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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFundacion Clinica Valle del Lili

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low segment hysterotomy

    Procedure/Surgery

    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/Surgery

    A high segment hysterotomy is a surgical procedure involving an incision in the upper segment of the uterus.

  • Crossed hysterorrhaphy

    Procedure/Surgery

    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/Surgery

    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

Treatment groups

168 Participants
are divided into 4 treatment groups
Group A: Low Segment Hysterotomy + Crossed hysterorrhaphyActive comparator 2 interventions
Group B: High Segment Hysterotomy + Crossed hysterorrhaphyExperimental treatment 2 interventions
Group C: Low Segment Hysterotomy + Non-Crossed hysterorrhaphyExperimental treatment 2 interventions
Group D: High Segment Hysterotomy + Non-Crossed hysterorrhaphyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.