Clinical trial NCT05863481: Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage
Official title: Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage: an Observational Study in a Danish Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Term
Cervical Insufficiency
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 185
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: Please see attached study protocol for further desricption.

Eligibility criteria: 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.

Primary outcomes:
measure: Neonatal survival (defined as survival at time of discharge from hospital)
timeFrame: From birth until discharge, an average of 8 weeks
Secondary outcomes:
measure: Number of neonates surviving with major neonatal morbidity
timeFrame: From birth until discharge, an average of 8 weeks
measure: Number of pregnancies
timeFrame: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
measure: Number of miscarriages
timeFrame: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
measure: Deliveries
timeFrame: From birth until discharge, an average of 8 weeks
measure: Number of uterine ruptures
timeFrame: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
measure: Time to first pregnancy (years and days)
timeFrame: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
Other outcomes:
measure: Neonatal characteristics
timeFrame: At delivery
measure: Number of early complications from the laparoscopic cerclage procedure
timeFrame: 30 days from the procedure
measure: Number of late complications from the laparoscopic cerclage procedure
timeFrame: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
Locations:
Study officials:
affiliation: Aarhus University Hospital/Aarhus University
name: Lise Q Krogh, MD
role: PRINCIPAL_INVESTIGATOR
References: