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

Cesarean Scar Defect Clinical Trial

— DICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717312
• Other study ID #: R15104
• Status: Completed
• Start date: January 2016
• Est. completion date: May 2021

Study information

• Verified date: September 2021
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2021
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Scar Defect
• Cicatrix

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (5)

Lead Sponsor	Collaborator
Tampere University Hospital	City of Tampere, Competitive State Research Funding of Tampere University Hospital, Finnish Medical Foundation, Tampere University Hospital Support Foundation

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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