Pre-TermNCT05863481
Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage
An observational study of Pre-Term and Cervical Insufficiency, run by University of Aarhus.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pre-Term, Cervical Insufficiency
- What is being tested?
- Laparoscopic cerclage placement
- Type of treatment
- Surgery or procedure
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2011to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Persons who underwent laparoscopic cerclage at Aarhus University Hospital, Denmark between May 2011 and May 2021
Who cannot join
- Persons who had their laparoscopic cerclage performed subsequently to a trachelectomy.
About this study
Official title: 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.
Read the detailed description
Please see attached study protocol for further desricption.
- Conditions
- Pre-Term, Cervical Insufficiency
- Being tested
- Laparoscopic cerclage placement
- Medical subject headings
- Premature Birth, Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cerclage placementProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic cerclage | Patients who underwent laparoscopic cerclage at Aarhus University Hospital, Denmark in the study period Receives: Procedure: Laparoscopic cerclage placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal survival (defined as survival at time of discharge from hospital)
no. (reported for first, and consecutive deliveries)
Measured: From birth until discharge, an average of 8 weeks
Secondary outcomes (6)
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)
Measured: From birth until discharge, an average of 8 weeks
Number of pregnancies
no.
Measured: 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.)
Measured: 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)
Measured: From birth until discharge, an average of 8 weeks
Number of uterine ruptures
no.
Measured: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
Time to first pregnancy (years and days)
no.
Measured: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 May 2011
- Primary completion31 May 2021
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-TermStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise Q Krogh, MD, Principal investigator, Aarhus University Hospital/Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863481
- Sponsor's protocol ID
- LapAUH
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage: an Observational Study in a Danish Cohort
- ClinicalTrials.gov ID
- NCT05863481
- Acronym / sponsor ID
- LapAUH
- Conditions
- Pre-Term, Cervical Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 May 2011 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic cerclage | – | Procedure: Laparoscopic cerclage placementPatients who underwent laparoscopic cerclage at Aarhus University Hospital, Denmark in the study period |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Persons who underwent laparoscopic cerclage at Aarhus University Hospital, Denmark between May 2011 and May 2021
Key exclusion criteria (1 listed)
- Persons who had their laparoscopic cerclage performed subsequently to a trachelectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cerclage placementThe 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) | Procedure or surgery | Laparoscopic cerclage |
Primary outcome
Neonatal survival (defined as survival at time of discharge from hospital)
Time frame: From birth until discharge, an average of 8 weeks
no. (reported for first, and consecutive deliveries)
6 secondary outcomes
Number of neonates surviving with major neonatal morbidity
Time frame: From birth until discharge, an average of 8 weeks
Number of pregnancies
Time frame: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
Number of miscarriages
Time frame: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
Deliveries
Time frame: From birth until discharge, an average of 8 weeks
Number of uterine ruptures
Time frame: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
Time to first pregnancy (years and days)
Time frame: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Q Krogh, MD principal investigator
Aarhus University Hospital/Aarhus University
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Term and Cervical Insufficiency, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal survival (defined as survival at time of discharge from hospital) (time frame: From birth until discharge, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.