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NCT Number: NCT06788873

Comparison of Cervical Cerclage by Vaginal and by Laparoscopic Transabdominal Routes in the Periconceptional Period

The goal of this observational study is to compare two different surgical techniques of performing elective cervical cerclage in the prevention of preterm delivery, both of which are already widely used in common clinical practice: elective cervical cerclage by the vaginal route and laparoscopic transabdominal elective cervical cerclage.

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Key information

Conditions

Cerclage, Cervical

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Elisa Montaguti, MD

CONTACT

[email protected]

0512144369

About this study

For the purpose of this study, no study-specific visits are planned. Data will be collected in a pseudo-anonymized manner, assigning each participant a sequence number.

For patients who undergo elective vaginal cervical cerclage at the division of Obstetrics and Prenatal Age Medicine or laparoscopic cerclage at the division of Gynecology and Human Reproductive Pathophysiology, the normal care pathway does not include additional follow-up visits for outpatient follow-up visits.

Regarding data collected in the past as part of the normal care pathway, patients will be asked to give informed consent in the context of a follow-up visit at which a practice staff member will be present.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with unfavorable obstetric history, i.e., at least two previous preterm deliveries or second-trimester abortions who underwent elective prophylactic cervical cerclage (vaginal or laparoscopic) between 01/01/2002 and 31/12/2020
  • Age ≥18 years
  • Obtaining informed consent form
  • Availability of clinical-demographic data

Exclusion criteria

  • Multiple pregnancy

Treatment and study plan

Data comparison

Other

For each participant, information will be collected on:

  • Gestational age at the time the cerclage was performed
  • Parity
  • Age
  • BMI
  • Ethnicity
  • Number of preterm deliveries
  • Gestational age of previous preterm deliveries
  • Previous uterine and/or cervix surgery (previous cerclage, conization, metroplasty, or other)
  • Type of cerclage performed
  • Operative times
  • Days of hospitalization
  • Surgical complications
  • Gestational age at the time of delivery
  • Mode of delivery (spontaneous, operative or cesarean)
  • Infant's weight at birth
  • Apgar at 1' and 5' minute
  • Ph newborn
  • Possible admission to neonatal intensive care unit.

Primary outcomes

  1. Comparison of elective cervical cerclage vaginally and laparoscopic transabdominal elective cervical cerclage

    Time frame: up to 100 weeks

    The patients for whom such treatment is reserved are those with unfavorable obstetrical history (at least 2 preterm deliveries or abortions in the second trimester of pregnancy), who have an extremely high risk of recurrence.

Secondary outcomes

  1. Comparison of maternal and fetal outcomes between the two groups

    Time frame: up to 100 weeks

    Live birth rate, gestational age at delivery, neonatal weight, and need for admission of the newborn to the Neonatal Intensive Care Unit (NICU).

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Montaguti, MD

CONTACT

[email protected]

0512144369

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Comparison of Elective Cervical Cerclage by Vaginal and by Laparoscopic Transabdominal Routes in the Periconceptional Period in the Patient with Unfavorable Obstetrical History

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

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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