Prevalence, Risk Factors and Consequences Related to Cesarean Scar Defect (Defect in Cesarean Scar) (DICE)

Defect in Cesarean Scar: A Prospective Study of Prevalence, Risk Factors and Impact on Menstrual Disorders and Quality of Life

The rates of cesarean section (CS) are rising all over the world. Worldwide the number of CS is millions every year. CS is one of the most frequently performed operation for women. As a consequence many women have a scar in their uterus. Cesarean scar may be associated with complications in later pregnancies. In recent years there have also been a few reports indicating that cesarean scar could potentially be associated with menstrual disorders and infertility. The impact of cesarean scar defect on long term welfare or quality of life is not clear.

In some women with a history of CS it is possible to recognise a defect in the site of previous uterotomy years after the performed CS by sonographic examination. This defect in the scar, also called as a niche, is a consequence of incomplete healing of the scar in the lower part of uterus. To date there is uncertainty relating to the factors that lead to poor healing of cesarean scar. Also impact of cesarean scar defect on later well-being and later pregnancies are not properly known.

The purpose of this study is to investigate the prevalence and the risk factors of cesarean scar defect. Also the impact of cesarean scar defect on women´s menstrual health, fertility, further deliveries and quality of life will be investigated.

This study is a prospective observational cohort study. Women at the age of 18-45 years who will give birth by elective or emergency CS will be asked to participate. Women are recruited within two days of CS. Women with known uterus anomaly or von Willebrand disease will be excluded.

The prevalence of scar defect will be evaluated by transvaginal sonography and contrast-enhanced sonohysterography using saline infusion. Both 2-dimensional and 3-dimensional sonography will be used. Sonographic evaluation will take place 6 months after the CS.

The following definition for CS scar defect will be used: myometrial discontinuity with a depth of ≥2 mm at the site of cesarean scar that communicates with the uterine or cervical cavity as seen on transvaginal sonography with or without saline infusion.

The prevalence of menstrual disorders will be evaluated 12 months after the CS. The subjects will be asked to report the number of menstrual bleeding days once a month during 3 consecutive months. Postmenstrual spotting is defined as ≥2 days of brownish discharge at the end of menstruation with total bleeding days of ≥7 or non-cyclic bleeding not related to menstruation.

Study Overview

• Status: Completed
• Conditions: Cesarean Scar Defect

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women undergoing cesarean section

Description

Inclusion Criteria:

• Women who gives birth by cesarean section whether it will be an elective surgery or an emergency surgery during labour

Exclusion Criteria:

• Uterus anomaly or von Willebrand disease
• Informed consent not provided

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between cesarean scar defect and post menstrual spotting	Postmenstrual spotting is defined as ≥2 days of brownish discharge at the end of menstrual bleeding with total bleeding days ≥7 or inter menstrual non-cyclic bleeding not related to menstruation.	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life related to cesarean scar defect	Quality of life related to cesarean scar defect will be assessed by using rand36 score.	10 years
Association between cesarean scar and adverse pregnancy outcome	Adverse pregnancy outcome includes spontaneous abortion, cesarean scar pregnancy, uterine rupture in later pregnancy and the rate of vaginal birth/cesarean section in later pregnancies.	10 years
Prevalence of cesarean scar defect measured by sonography	Number of participants with cesarean scar defect. Cesarean scar defect is defined as myometrial discontinuity with a depth of ≥2 mm at the site of cesarean scar that communicates with the uterine or cervical cavity as seen on transvaginal sonography with or without saline infusion.	6 months
Impact of cervical opening at the time of cesarean section on the prevalence of cesarean scar defect.	Association between cervical opening at the time of operation (cm) and detected cesarean scar defect (6 months after the operation).	6 months

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Finnish Medical Foundation; City of Tampere; Competitive State Research Funding of Tampere University Hospital; Tampere University Hospital Support Foundation
• Investigators: Study Director: Synnöve Staff, MC PhD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: R15104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No