Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage

NCT05863481 | Completed

• 1 other identifier: LapAUH
• Study Type: observational
• Target: 185
• Locations: 0 countries
• Sites: N/A

Brief Summary

Preterm birth is a leading cause of neonatal mortality and morbidity. Cervical insufficiency is one factor implicated in the complex mechanisms involved in spontaneous preterm birth. Trans-abdominal insertion of a cervical cerclage suture can be used to treat cervical insufficiency. Growing evidence support that laparoscopic cerclage procedures are safe and effective. Still, many aspects of the laparoscopic cerclage remains uncertain. Therefore, the investigators plan to study the obstetric outcome from the first and subsequent pregnancies after laparoscopic cerclage in a Danish cohort from Aarhus University Hospital in a 10 years' period.

Conditions

Pre-Term; Cervical Insufficiency

Outcome Measures

Primary Outcomes (1)

• Neonatal survival (defined as survival at time of discharge from hospital)

  no. (reported for first, and consecutive deliveries)

  From birth until discharge, an average of 8 weeks

Secondary Outcomes (6)

• Number of neonates surviving with major neonatal morbidity

  From birth until discharge, an average of 8 weeks

• Number of pregnancies

  From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)

• Number of miscarriages

  From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)

• Deliveries

  From birth until discharge, an average of 8 weeks

• Number of uterine ruptures

  From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)

Other Outcomes (3)

• Neonatal characteristics

  At delivery

• Number of early complications from the laparoscopic cerclage procedure

  30 days from the procedure

• Number of late complications from the laparoscopic cerclage procedure

  From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)

Study Arms (1)

Laparoscopic cerclage

Patients who underwent laparoscopic cerclage at Aarhus University Hospital, Denmark in the study period

Procedure: Laparoscopic cerclage placement

Interventions

Laparoscopic cerclage placement PROCEDURE

The surgical method of the laparoscopic cerclage procedure at Aarhus University Hospital previous described in a paper by Riiskjaer et al (DOI: 10.1111/aogs.12001)

Laparoscopic cerclage

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons at risk of preterm birth who were offered and underwent laparoscopic cerclage surgery at Aarhus University Hospital, Denmark in the period from May 2011 till May 2021.

You may qualify if:

• Persons who underwent laparoscopic cerclage at Aarhus University Hospital, Denmark between May 2011 and May 2021

You may not qualify if:

• Persons who had their laparoscopic cerclage performed subsequently to a trachelectomy.

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Conditions

Premature Birth; Uterine Cervical Incompetence

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Genital Diseases

Study Officials

• Lise Q Krogh, MD

  Aarhus University Hospital/Aarhus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 18, 2023
• Study Start: May 1, 2011
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-05