Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage

Completed

• Conditions: Cervical Insufficiency; Pre-Term
• Interventions: Procedure: Laparoscopic cerclage placement

• Registration Number: NCT05863481
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2011-05-01
• Primary Completion: 2021-05-31
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-18
• Study Completion: 2023-05-31
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 185

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic cerclage	Laparoscopic cerclage placement	Patients who underwent laparoscopic cerclage at Aarhus University Hospital, Denmark in the study period

Primary Outcome Measures

Name	Time	Method
Neonatal survival (defined as survival at time of discharge from hospital)	From birth until discharge, an average of 8 weeks	no. (reported for first, and consecutive deliveries)

Secondary Outcome Measures

Name	Time	Method
Deliveries	From birth until discharge, an average of 8 weeks	* Deliveries \<28 weeks and 0 days of an infant living (no.); * Deliveries \<32 weeks and 0 days of an infant living (no.); * Deliveries \<34 weeks and 0 days of an infant living (no.); * Deliveries \<37 weeks and 0 days of an infant living (no.) (reported for first, and consecutive deliveries)
Number of uterine ruptures	From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)	no.
Time to first pregnancy (years and days)	From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)	no.
Number of neonates surviving with major neonatal morbidity	From birth until discharge, an average of 8 weeks	* Necrotising enterocolitis (NEC) (no.); * Bronchopulmonary Dysplasia (BPD) (defined as respiratory/oxygen support at postmenstrual age (PMA) 36 weeks) (no.); * Intraventricular haemorrhage (IVH) Grade III and IV (no.); * Hydrocephalus with ventriculoperitoneal (VP) shunt (no.); * Periventricular leukomalacia (no.); * Retinopathy of prematurity (ROP) (no.) (Reported for first, and consecutive deliveries)
Number of pregnancies	From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)	no.
Number of miscarriages	From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)	* Early miscarriages (\<16 weeks and 0 days) (no.); * Late miscarriages (\<22 weeks and 0 days) (no.)