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THYRI Project: Two-plane uterine suture to decrease myometrial dehiscence in the cesarean site.

THYRI Project: Two-Plane Hysterorrhaphy to Reduce Isthmocele

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2y8jkqb
Enrollment
Unknown
Registered
2025-06-28
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other abnormal uterine and vaginal bleeding

Interventions

This is a randomized, controlled, double-blind, two-arm clinical trial. Experimental group: 134 women undergoing elective cesarean section with a unlocked, double-layer hysterorrhaphy. Control group:

Sponsors

Faculdade de Medicina de Jundiaí
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Pregnant woman submitted to the first cesarean section; pregnant woman submitted to lower-segment transverse cesarean section; woman with singleton pregnancy; no minimum or maximum age limit; feminine gender

Exclusion criteria

Exclusion criteria: Pregnant woman with myoma in the segment region of the uterus; woman submitted to emergency/urgent c-sections; woman with placenta previa

Design outcomes

Primary

MeasureTime frame
Reduction in the incidence of istmocele (according to the Delphi-Jordans consensus): diagnosed by imaging studies, such as transvaginal ultrasound or diagnostic hysteroscopy

Secondary

MeasureTime frame
Increase in residual myometrial thickness (according to the Delphi-Jordans consensus): diagnosed by imaging studies such as transvaginal ultrasound, measured in millimeters;Reduction of cyclic pelvic pain: Measured based on the participant's self-reported experience of cyclical perimenstrual pain, categorized as present or absent;Reduction of abnormal uterine bleeding: A categorical quantitative variable, based on the participant's self-reported perception of menstrual pattern characteristics and the criteria of the Menstrual Bleeding Questionnaire

Countries

Brazil

Contacts

Public ContactRenato Souza

Faculdade de Medicina de Jundiaí

rtsouza@unicamp.br+55(19)99110-7984

Outcome results

None listed

Source: REBEC (via WHO ICTRP)