NCT04073264

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

August 26, 2019

Last Update Submit

August 21, 2021

Conditions

Cesarean Scar Defect

Outcome Measures

Primary Outcomes (1)

  • incidence of cesarean scar defects at ultrasound 6-months follow-up

    6-months follow-up after cesarean

Secondary Outcomes (3)

  • incidence of scar defects at hysteroscopy at 6 months follow-up

    6-months follow-up after cesarean

  • Symptoms of cesarean scar defect

    6-months follow-up after cesarean

  • RMT

    6-months follow-up after cesarean

Study Arms (2)

monofilament

EXPERIMENTAL

monofilament absorbable suture

Procedure: monofilament

polifilament

ACTIVE COMPARATOR

synthetic absorbable braided (polifilament) suture

Procedure: monofilament

Interventions

monofilamentPROCEDURE

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

monofilamentpolifilament

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gabriele Saccone

Napoli, 80129, Italy

Location

Related Publications (1)

  • 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.

    PMID: 35131497DERIVED

MeSH Terms

Interventions

Saran

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 29, 2019

Study Start

September 1, 2019

Primary Completion

July 20, 2021

Study Completion

July 25, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)