Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage

Study Overview
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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.

Official Title
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Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage: an Observational Study in a Danish Cohort

Conditions
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Pre-Term, Cervical Insufficiency

Intervention / Treatment
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* Procedure: Laparoscopic cerclage placement


Participation Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic cerclage<br>Patients who underwent laparoscopic cerclage at Aarhus University Hospital, Denmark in the study period | Procedure: Laparoscopic cerclage placement<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of neonates surviving with major neonatal morbidity | 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) | From birth until discharge, an average of 8 weeks | 
| Number of pregnancies | no. | From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends) | 
| Number of miscarriages | Early miscarriages (<16 weeks and 0 days) (no.) Late miscarriages (<22 weeks and 0 days) (no.) | From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends) | 
| Deliveries | 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) | From birth until discharge, an average of 8 weeks | 
| Number of uterine ruptures | no. | From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends) | 
| Time to first pregnancy (years and days) | no. | From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends) |