Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage

Pre-Term Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05863481
• Other study ID #: LapAUH
• Status: Completed
• Start date: May 1, 2011
• Est. completion date: May 31, 2023

Study information

• Verified date: May 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Please see attached study protocol for further desricption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Insufficiency
• Pre-Term
• Uterine Cervical Incompetence

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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)
Primary	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	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
Secondary	Number of pregnancies	no.	From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
Secondary	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)
Secondary	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
Secondary	Number of uterine ruptures	no.	From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
Secondary	Time to first pregnancy (years and days)	no.	From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)