Long-Term Patient-Reported Maternal Outcomes Following Abdominal Cerclage for the Prevention of Preterm Birth

University of Aarhus

Status: Invitation-only

Conditions: Cerclage, Cervical; Cervical Insufficiency

Treatments: Procedure: Abdominal cerclage (open or laparoscopic)

Study type: Observational

Funder types: Other

Identifiers

NCT06875401

1-45-70-80-24

Details and patient eligibility

About

This study aims to explore the maternal patient reported outcomes on pelvic pain sexual health anxiety and depression bladder discomfort foreign body sensation trust in the cerclage, and how these parameters affect the general health perception in the quality of life of women treated with abdominal cerclages in Denmark since 2004.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Transabdominal cerclage

Exclusion criteria

• Most recent birth within 6 months

Trial design

1,200 participants in 4 patient groups

Transabdominal cerclage

Description:

Participants with a transabdominal cerclage and subsequent birth

Treatment:

Procedure: Abdominal cerclage (open or laparoscopic)

No abdominal cerclage, CS

Description:

Participants with no abdominal cerclage, but previous caesarean section. Participants matched on birth mode and -year, and age at time of cohort entry.

No abdominal cerclage, vaginal birth

Description:

Participants matched on birth year and age at time of cohort entry. Participants with a history of C-section and/or instrumental deliveries cannot enter this comparison group.

Women with a transabdominal cerclage and no subsequent birth

Description:

Participants who underwent the abdominal cerclage procedure, but did not become pregnant after the procedure.

Treatment:

Procedure: Abdominal cerclage (open or laparoscopic)