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Assessment of uterine scar immediately after cesarean section. Influence of wire with barbs on ultrasound of the scar defect

Early assessment of cesarean section scar. Influence of Barbed Wire on the ultrasound characteristics of the Niche

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6jcj8k3
Enrollment
Unknown
Registered
2024-02-21
Start date
2023-02-12
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

Cesarean Section

Interventions

This is a two-arm, double-blind, randomized controlled clinical study. Experimental group: Cesarean section was performed on 40 pregnant women suturing the uterus with #1 barbed PDS thread in the uter
administration of prophylactic antibiotics for 24 h
and administration of oxytocin for a maximum of 24 h. Randomization into 6 blocks of 10 pregnant women at a 1:1 ratio due to the expected loss of exclusion of 15% of participants due to exclusion crit

Sponsors

Faculdade de Medicina - Universidade Federal de Mato Grosso do Sul
Lead Sponsor
Hospital Universitário Maria Aparecida Pedrossian
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Pregnancy. Age 18 years old and over. Without cesarean section

Exclusion criteria

Exclusion criteria: Uncontrolled gestational diabetes. Peripartum anemia. Chronic use of corticosteroids. Multiple pregnancy. Polyhydramnios. Domicile outside the city of Campo Grande. Mullerian anomalies. Placenta previa. Chronic inflammatory disease. Chorioamnionitis. Fever of any nature. Infection in the topography of the incision. Myoma at the hysterotomy site. Uterine incision in the body segment. More than 2 extra stitches for hemostasis. Endometritis. Uterine resuturing in the postpartum. Use of corticosteroids up to 30 days postpartum

Design outcomes

Primary

MeasureTime frame
It is expected to find the presence of uterine scar dehiscence in the immediate postpartum period (second postpartum day) through transvaginal ultrasound, compatible with the observation of 62% of uterine scar defects observed 6 months after the first cesarean section reported by other authors. The assessment of the primary outcome will be qualitative with the presence or absence of dehiscence. The precocity of this defect is hypothesized but has not been documented to date.

Secondary

MeasureTime frame
It is expected to find dehiscence with a greater width in the uterine scar with the #0 polyglactin thread in relation to the #1 PDS barbed thread in the proportion of 20.2% vs 32.6% as reported in the literature despite the difference in the suturing technique and interval of ultrasound analysis.;It is expected to find dehiscence with a greater width in the uterine scar with the #0 polyglactin thread in relation to the #1 PDS barbed thread in the proportion of 20.2% vs 32.6% as reported in the literature despite the difference in the suturing technique and interval of ultrasound analysis.

Countries

Brazil

Contacts

Public ContactNewton Ishikawa

Programa de Pós Graduação Saúde e Desenvolvimento na Região Centro-Oeste

newtondpi@hotmail.com+55 (67) 999856828

Outcome results

None listed

Source: REBEC (via WHO ICTRP)