Pregnancy Outcomes Following Myomectomy (POFM)

January 22, 2026 updated by: Centro di Ricerca Clinica Salentino

Pregnancy Outcomes Following Hysteroscopic, Laparoscopic and Laparotomic Myomectomy

The most prevalent genital pathology, uterine fibroids have a detrimental impact on the health of women. Fibroid symptoms are typically more impactful on females and frequently require uterine excision. Although contentious in terms of how it affects pregnancy outcomes, hysteroscopic, laparoscopic, or laparotomic myomectomy has always been a necessary and suitable procedure for the patient's health. Numerous studies have been conducted on the topic, but no clear findings have been reached.

The goal of this observational study is to investigate the pregnancy outcomes after hysteroscopic, laparoscopic, laparotomic myomectomies in female patients affected by fibroids. The main questions it aims to answer are:

To investigate pregnancy outcomes in relation to surgical approach used for myomectomy.

To investigate whether pregnancy outcome is different in relation to time when myomectomy was performed: on a pregnant uterus or on a non-gravid uterus.

If there is a comparison group: Researchers will compare a group of patients unsubmitted to surgery, to see the difference with the operated patients.

Participants will follow up, to evaluate the possible pregnancy complications, the intraoperative complications and other perinatal and post-operative complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

AIMS:

  1. To investigate pregnancy outcomes in relation to surgical approach used for myomectomy.
  2. To investigate if pregnancy outcome is different in relation to time when myomectomy was performed: on a gravid uterus or on a non-gravid uterus

Patients enrolled are divided in three major groups:

  • Group A: myomectomy outside of pregnancy-A1 hysteroscopic; A2 laparoscopic; A3 laparotomy
  • Group B: myomectomy during CS: B1 trans-endometrial; B2 serosal
  • Group C: control group with repeated CS

INCLUSION CRITERIA:

  1. women of reproductive age (up to 45 yrs)-all groups
  2. women who had myomectomy (group A and B)/CS (group C) at least two years before the enrolment
  3. myomas 30 mm in size and larger (groups A and B)
  4. Study groups: myomectomy performed as hysteroscopic/laparoscopic/laparotomic myomectomy or cesarean myomectomy, both using transendometrial or serosal approach: gravida 2 para 2 or gravida 1 para 1 [groups A1, A2, A3 and groups B1 and B2]
  5. Control group: women who had cesarean section in their second pregnancy-para 2 gravida 2, at least two years after the CS [group C]

EXCLUSION CRITERIA:

  1. any previous surgery on reproductive organs except myomectomy
  2. any additional operation during cesarean myomectomy procedure except cesarean section
  3. history of endometriosis or PID
  4. coagulation disorders
  5. previous treatment for any malignant disease
  6. previous GTD
  7. premature ovarian failure or any kind of ovarian insufficiency necessitating oocyte donation
  8. systemic diseases: IBD, MS, DM

DATA TO COLLECT:

  1. age
  2. years after myomectomy or CS(for group C)
  3. gravidity
  4. parity
  5. BMI
  6. myoma characteristics (size and type)
  7. myomectomy procedure
  8. gestational week at delivery
  9. primary indication for CS
  10. fetal position
  11. placental pathology
  12. preoperative hematologic values
  13. postoperative hematologic values
  14. duration of the CS
  15. myoma recurrence in groups A and B
  16. uterine rupture
  17. perioperative transfusion
  18. febrile morbidity
  19. postoperative hospitalization in days
  20. PPH
  21. cause of PPH
  22. uterine atony
  23. relaparotomy
  24. hysterectomy
  25. blood vessels ligation
  26. fetal presentation: cephalic/other
  27. neonatal body weight
  28. Apgar score

OUTCOMES:

  1. pregnancy complications

    1. placental pathology: placenta previa, placental abruption, PAS
    2. PPROM (gestational age)
    3. abnormal presentation: cephalic/other
    4. uterine rupture: complete/incomplete
    5. preterm/term delivery (gestational age at delivery)

  2. intraoperative complications

    1. intraabdominal adhesions/PAI score
    2. surgery complications: Claven Dindo classification

  3. other complications:

    1. neonatal outcome,
    2. duration of maternal hospitalization,
    3. primary or secondary PPH
    4. primary or secondary PPH
    5. relaparotomy
    6. peripartum hysterectomy,
    7. ligation of major blood vessels (uterine, ovarian, iliac)

The study will be conducted as a multicentric observational study including cesarean section deliveries in each participating center. In each participating center, one person will be in charge for data collection and filling the SPSS database after obtaining the approval of the local Ethic Committee. As the study is observational and all the procedures will be conducted according to the local practice, informed consent from patients is not necessary.

Following data collection and termination of the study, a single researcher will oversee the SPSS data collection for all the participating centers, checking the quality of data and submitting it for statistical analysis.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Le
      • Lecce, Le, Italy, 73100
        • Andrea Tinelli

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients to submit to myoemctomy, are divided in three major groups:

  • Group A: myomectomy outside of pregnancy-A1 hysteroscopic; A2 laparoscopic; A3 laparotomy
  • Group B: myomectomy during CS: B1 trans-endometrial; B2 serosal
  • Group C: control group with repeated CS

Description

Inclusion Criteria:

  1. women of reproductive age (up to 45 yrs)-all groups
  2. women who had myomectomy (group A and B)/CS (group C) at least two years before the enrolment
  3. myomas 30 mm in size and larger (groups A and B)
  4. Study groups: myomectomy performed as hysteroscopic/laparoscopic/laparotomic myomectomy or cesarean myomectomy, both using transendometrial or serosal approach: gravida 2 para 2 or gravida 1 para 1 [groups A1, A2, A3 and groups B1 and B2]
  5. Control group: women who had cesarean section in their second pregnancy-para 2 gravida 2, at least two years after the CS [group C]

Exclusion Criteria:

  1. any previous surgery on reproductive organs except myomectomy
  2. any additional operation during cesarean myomectomy procedure except cesarean section
  3. history of endometriosis or PID
  4. coagulation disorders
  5. previous treatment for any malignant disease
  6. previous GTD
  7. premature ovarian failure or any kind of ovarian insufficiency necessitating oocyte donation
  8. systemic diseases: IBD, MS, DM

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
Intervention / Treatment
Treated patiens' Group as Group 1
Patients submitted to hysteroscopic, laparoscopic or laparotomic myomectomy
Procedure: Myomectomy
Patients submitted to operation of fibroids removal
Untreated patiens' Group as Group 2
Control group - unoperated patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy complications
Time Frame: 1 year
placental pathology, intraoperative complications, other complications
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative complications
Time Frame: 1 year
intraabdominal adhesions/PAI score, surgical complications: Claven Dindo classification
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
other complications
Time Frame: 1 year
neonatal outcome, duration of maternal hospitalization, Primary or secondary PPH, relaparotomy, peripartum hysterectomy, ligation of major blood vessels
1 year

Collaborators and Investigators

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

Sponsor

Centro di Ricerca Clinica Salentino

Collaborators

Alper Başbuğ

Investigators

  • Principal Investigator: Andrea Tinelli, MD, Centro di Ricerca Clinica Salentino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 28, 2024

Primary Completion (Actual)

October 30, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER 0324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

I am considering making individual participant data (IPD) available to other researchers.

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

I'm considering to make IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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