Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage

August 1, 2023 updated by: University of Aarhus

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Please see attached study protocol for further desricption.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
From birth until discharge, an average of 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of neonates surviving with major neonatal morbidity
Time Frame: 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)
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)
no.
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)
  • 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
Time Frame: 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)
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)
no.
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)
no.
From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neonatal characteristics
Time Frame: 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)
At delivery
Number of early complications from the laparoscopic cerclage procedure
Time Frame: 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.)
30 days from the procedure
Number of late complications from the laparoscopic cerclage procedure
Time Frame: 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.)
From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lise Q Krogh, MD, Aarhus University Hospital/Aarhus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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