Isthmocele After Two Different Sutures in Cesarean Section

NCT ID: NCT04073264

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-07-25

Brief Summary

Cesarean delivery (CD) rates are rising globally. about 30% of women delivered by CD in 2015 only in the USA. This increasing CD rate has stimulated an interest in the potential short- and long-term morbidity of CD scars. In more than 50% of women with history of CD, a uterine scar defect, also called a "isthmocele," defined as a disruption of the myometrium in the CD uterine scar, can be observed when examined by gel instillation sonohysterography 6-12 months after the CD. Uterine scar defects detected on ultrasound have been associated with prolonged menstrual bleeding and postmenstrual spotting, as well as with an increased risk of several obstetrical complications in subsequent pregnancies, including uterine dehiscence and/or rupture, scar pregnancy and placenta previa and accreta. Another screening method associated with uterine scar rupture in women with prior CD is ultrasonographic measurement of the thickness of the lower uterine segment, as pioneered by Rozenberg et al. in 1996. A meta-analysis by Kok et al. supports the use of the residual myometrial thickness (RMT) for predicting uterine rupture during vaginal birth after cesarean. Uterine scar defects have been associated with lower RMT.

A growing body of evidence suggests that the surgical technique for uterine closure influences uterine scar healing and the RMT, but there is still no consensus about optimal uterine closure and type of suture. It is imperative to have evidence-based guidelines for each surgical step before recommending one technique over another.

The aim of our trial is to evaluate the incidence of cesarean scar defect according to type of suture at the time of cesarean

Conditions

Cesarean Scar Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

monofilament

monofilament absorbable suture

Group Type: EXPERIMENTAL

monofilament

Intervention Type: PROCEDURE

In the intervention group,monofilament absorbable suture,will be used.

polifilament

synthetic absorbable braided (polifilament) suture

Group Type: ACTIVE_COMPARATOR

monofilament

Intervention Type: PROCEDURE

In the intervention group,monofilament absorbable suture,will be used.

Interventions

monofilament

In the intervention group,monofilament absorbable suture,will be used.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Pregnant women with singleton gestations
• Between ≥37 and ≤42 gestational age
• >18 <45 years
• Undergoing primary or secondary elective or urgent cesarean delivery

Exclusion Criteria

• Multiple gestations
• Preterm cesarean
• 2 or more prior cesarean deliveries
• Uterine malformations
• Prior myomectomy
• Placenta accreta/previa

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Saccone

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gabriele Saccone

Napoli, , Italy

Countries

Italy

References

Saccone G, De Angelis MC, Zizolfi B, Gragnano E, Musone M, Zullo F, Bifulco G, Di Spiezio Sardo A. Monofilament vs multifilament suture for uterine closure at the time of cesarean delivery: a randomized clinical trial. Am J Obstet Gynecol MFM. 2022 May;4(3):100592. doi: 10.1016/j.ajogmf.2022.100592. Epub 2022 Feb 4.

Reference Type: DERIVED

PMID: 35131497 (View on PubMed)

Other Identifiers

129/19

Identifier Type: -

Identifier Source: org_study_id