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Completed

NCT Number: NCT05863481

Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage

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.

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Key information

Conditions

Pre-Term Abortion, Habitual Abortion, Spontaneous Cervical Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Incompetence Uterine Diseases

Sex eligibility

Female

Study type

Observational

About this study

Please see attached study protocol for further desricption.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic cerclage placement

Procedure

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)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Number of pregnancies

    Time frame: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)

    no.

  3. 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.)

  4. 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)

  5. Number of uterine ruptures

    Time frame: From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends)

    no.

  6. 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.

Other outcomes

  1. 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)

  2. 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.)

  3. 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.)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2021
Study completion
2023
First posted
May 18, 2023
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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