Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Insufficiency; Pre-Term
• Intervention / Treatment: Procedure: Laparoscopic cerclage placement

Detailed Description

Please see attached study protocol for further desricption.

• Study Type: Observational
• Enrollment (Actual): 185

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal characteristics	Gestational age (weeks and days) (no.); Birthweight (grams) (Reported for deliveries with a gestational age ≥ 20 weeks and 0 days - allow missing data)	At delivery
Number of early complications from the laparoscopic cerclage 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.)	30 days from the procedure
Number of late complications from the laparoscopic cerclage procedure	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.)	From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Lise Q Krogh, MD, Aarhus University Hospital/Aarhus University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Cervical Diseases; Uterine Diseases; Pregnancy Complications; Abortion, Habitual; Abortion, Spontaneous; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Incompetence
• Other Study ID Numbers: LapAUH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No