Cervical Insufficiency, Pre-Term
Conditions
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.
Interventions
PROCEDURELaparoscopic 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)
Sponsors
University of Aarhus
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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.) |
| 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.) |
Outcome results
None listed