NCT06009562

Brief Summary

The frequency of women presenting with a combination of uterine fibroids and pregnancy is in-creasing nowadays. Uterine fibroids in pregnancy are an unfavorable condition in themselves and being reactive to hormonal stimuli, tending to grow, can generate symptoms of different lev-els of severity. Obstetrics and gynecologists are increasingly faced with the problem of clarifying the management tactics of pregnant patients with symptomatic fibroids, who may see their preg-nancy put at risk by these masses.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 19, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

August 19, 2023

Last Update Submit

August 19, 2023

Conditions

Uterine FibroidPregnancy Related

Keywords

Uterine fibroidsPregnancymyomectomyfetal outcomes

Outcome Measures

Primary Outcomes (1)

  • continuation of pregnancy

    Pregnancy continuation after surgery.

    5 months

Secondary Outcomes (1)

  • Fetal outcome

    5 months

Interventions

Laparotomic myomectomy during pregnancyPROCEDURE

Surgical removal of symptomatic uterine fibroids in pregnancy by laparotomic access

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnant women with symptomatic uterine fibroids (UFs)

You may qualify if:

  • The large and giant size of UFs, which prevent the proper continuation of pregnancy and/or occupy the entire small and large pelvis, as well as invade and/or occupy the abdominal cavity.
  • Circulatory disorders, evidenced by necrosis of the UFs.
  • Atypical localization of UFs (cervical, isthmic, intraligamentary, etc.), which caused pelvic organ dysfunction (dysuric phenomena, tenesmus, impediment to the act of defecation, pelvic pain).

You may not qualify if:

  • Refusal of LPTM by the patient.
  • Absence of urgent indication for LPTM during pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State-Funded Health Care Facility of Moscow Region (GBUZ MO MONIIAG)

Moscow, 101000, Russia

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Andrea Etrusco, M.D.

    University of Palermo

    PRINCIPAL INVESTIGATOR

  • Antonio Simone Laganà, M.D. Ph.D.

    University of Palermo

    STUDY DIRECTOR

Central Study Contacts

Andrea Etrusco, M.D.

CONTACT

3881614022etruscoandrea@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 19, 2023

First Posted

August 24, 2023

Study Start

August 19, 2023

Primary Completion

August 19, 2023

Study Completion

January 1, 2024

Last Updated

August 24, 2023

Record last verified: 2023-08

Locations

RU(1)