Pre-Term Clinical Trial
Official title:
Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage: an Observational Study in a Danish Cohort
NCT number | NCT05863481 |
Other study ID # | LapAUH |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2011 |
Est. completion date | May 31, 2023 |
Verified date | May 2023 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
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) |
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