Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT05863481

Collaborator

(none)

185

Enrollment

121

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-Term Cervical Insufficiency	Procedure: Laparoscopic cerclage placement

Detailed Description

Please see attached study protocol for further desricption.

Study Design

Study Type:

Observational

Actual Enrollment :

185 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 1, 2011

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Laparoscopic cerclage Patients who underwent laparoscopic cerclage at Aarhus University Hospital, Denmark in the study period	Procedure: 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)

Arm

Intervention/Treatment

Laparoscopic cerclage

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

Procedure: 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)

Outcome Measures

Primary Outcome Measures

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

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.)
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.

Other Outcome Measures

Neonatal characteristics [At delivery]
Gestational age (weeks and days) (no.) Birthweight (grams) (Reported for deliveries with a gestational age ≥ 20 weeks and 0 days - allow missing data)
Number of early complications from the laparoscopic cerclage procedure [30 days from the procedure]
Conversion to laparotomy during surgery (no.) Haemorrhage > 500 ml (no.) Postoperative infection treated at hospital (no.) Damage to internal organs (no.) Need for re-operation (no.) Admission to Intensive Care Unit (no.) Thromboembolic events (defined as deep vein thrombosis, pulmonary embolism or stroke) (no.) Maternal cardiopulmonary arrest (no.) Maternal death (no.)
Number of late complications from the laparoscopic cerclage procedure [From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)]
Erosion into the vagina treated in hospital (no.) Pain complaints from the stiches leading to intervention in pregnancy (no.) Other complications from the cerclage leading to intervention in hospital (no.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

No further exclusion criteria are defined

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator: Lise Q Krogh, MD, Aarhus University Hospital/Aarhus University

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT05863481

Other Study ID Numbers:

LapAUH

First Posted:

May 18, 2023

Last Update Posted:

May 18, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Cervical Incompetence

Study Results

No Results Posted as of May 18, 2023