Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage

NCT ID: NCT05863481

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-01

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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Please see attached study protocol for further desricption.

Conditions

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Pre-Term Cervical Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Laparoscopic cerclage

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

Laparoscopic cerclage placement

Intervention Type 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)

Interventions

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Laparoscopic cerclage placement

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)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Persons who had their laparoscopic cerclage performed subsequently to a trachelectomy.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lise Q Krogh, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital/Aarhus University

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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LapAUH

Identifier Type: -

Identifier Source: org_study_id

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