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Uterine FibroidNCT06474065

Pregnancy Outcomes Following Myomectomy

An observational study of Uterine Fibroid and Pregnancy Complications, run by Centro di Ricerca Clinica Salentino at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 25 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Myomectomy
Type of treatment
Surgery or procedure
How many people
150 participants
Where
1 siteItaly
Study dates
28 Jun 2024to 30 Dec 2025
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • women of reproductive age (up to 45 yrs)-all groups
  • women who had myomectomy (group A and B)/CS (group C) at least two years before the enrolment
  • myomas 30 mm in size and larger (groups A and B)
  • 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]
  • Control group: women who had cesarean section in their second pregnancy-para 2 gravida 2, at least two years after the CS [group C]

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Andrea Tinelli

    Lecce, Le, 73100

Other trials in Italy

About this study

Official title: 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:

Read more

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.

Read the 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
  2. placental pathology: placenta previa, placental abruption, PAS
  3. PPROM (gestational age)
  4. abnormal presentation: cephalic/other
  5. uterine rupture: complete/incomplete
  6. preterm/term delivery (gestational age at delivery)
  7. intraoperative complications
  8. intraabdominal adhesions/PAI score
  9. surgery complications: Claven Dindo classification
  10. other complications:
  11. neonatal outcome,
  12. duration of maternal hospitalization,
  13. primary or secondary PPH
  14. primary or secondary PPH
  15. relaparotomy
  16. peripartum hysterectomy,
  17. 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.

Being tested
Myomectomy
Keywords
Fibroids, Leiomyoma, Myomectomy, Outcome, Pregnancy
Medical subject headings
Leiomyoma, Pregnancy Complications, Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MyomectomyProcedure or surgery

    Patients submitted to operation of fibroids removal

Study groups in NCT06474065
Study groupRoleWhat they receive
Treated patiens' Group as Group 1Patients submitted to hysteroscopic, laparoscopic or laparotomic myomectomy
Receives: Procedure: Myomectomy
Untreated patiens' Group as Group 2Control group - unoperated patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pregnancy complications

    placental pathology, intraoperative complications, other complications

    Measured: 1 year

Secondary outcomes (1)

  1. Intraoperative complications

    intraabdominal adhesions/PAI score, surgical complications: Claven Dindo classification

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2024
  2. Study start28 Jun 2024
  3. Primary completion30 Oct 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
150 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06474065
Sponsor's protocol ID
CER 0324
Status last verified
Jan 2026
First submitted
19 Jun 2024
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: I am considering making individual participant data (IPD) available to other researchers.

Publications

  • Hatirnaz S, Guler O, Basbug A, Cetinkaya MB, Kanat-Pektas M, Bakay K, Celik S, Senturk S, Soyer-Caliskan C, Gurcaglar A, Sahin B, Kalkan U, Celik H, Kalyoncu S, Biyik I, Yassa M, Erol O, Akarsu S, Turhan U, Ulubasoglu H, Sparic R, Tinelli A. A Comparative Multicentric Study on Serosal and Endometrial Myomectomy During Cesarean Section: Surgical Outcomes. J Invest Surg. 2021 Jul;34(7):687-694. doi: 10.1080/08941939.2020.1725188. Epub 2020 Feb 17.

    PubMed 32064967

  • Sparic R, Andric L, Guler O, Malvasi A, Babovic I, Hatirnaz S, Dellino M, Tinelli A. Cesarean Myomectomy: Reflections on Clinical and Surgical Controversies between a New Trans-Decidual Technique vs. Traditional Method. Medicina (Kaunas). 2024 Apr 8;60(4):609. doi: 10.3390/medicina60040609.

    PubMed 38674255

  • Hatirnaz S, Guler O, Basaranoglu S, Tokgoz C, Kilic GS. Endometrial myomectomy: a novel surgical method during cesarean section. J Matern Fetal Neonatal Med. 2018 Feb;31(4):433-438. doi: 10.1080/14767058.2017.1286320. Epub 2017 Feb 9.

    PubMed 28114870

  • Tinelli A, Kosmas I, Medvediev MV, Malvasi A, Morciano A, Sparic R, Mynbaev OA. Myomectomy in adult women of reproductive age: a propensity score-matched study for pregnancy rates. Arch Gynecol Obstet. 2023 Oct;308(4):1351-1360. doi: 10.1007/s00404-023-07135-0. Epub 2023 Jul 14.

    PubMed 37450263

  • Tinelli A, Hurst BS, Hudelist G, Tsin DA, Stark M, Mettler L, Guido M, Malvasi A. Laparoscopic myomectomy focusing on the myoma pseudocapsule: technical and outcome reports. Hum Reprod. 2012 Feb;27(2):427-35. doi: 10.1093/humrep/der369. Epub 2011 Nov 16.

    PubMed 22095838

  • Sparic R, Papoutsis D, Bukumiric Z, Kadija S, Spremovic Radjenovic S, Malvasi A, Lackovic M, Tinelli A. The incidence of and risk factors for complications when removing a single uterine fibroid during cesarean section: a retrospective study with use of two comparison groups. J Matern Fetal Neonatal Med. 2020 Oct;33(19):3258-3265. doi: 10.1080/14767058.2019.1570124. Epub 2019 Jan 30.

    PubMed 30700185

  • Tinelli A, Malvasi A, Mynbaev OA, Barbera A, Perrone E, Guido M, Kosmas I, Stark M. The surgical outcome of intracapsular cesarean myomectomy. A match control study. J Matern Fetal Neonatal Med. 2014 Jan;27(1):66-71. doi: 10.3109/14767058.2013.804052. Epub 2013 Jun 20.

    PubMed 23662726

  • Sparic R, Malvasi A, Kadija S, Stefanovic A, Radjenovic SS, Popovic J, Pavic A, Tinelli A. Safety of cesarean myomectomy in women with single anterior wall and lower uterine segment myomas. J Matern Fetal Neonatal Med. 2018 Aug;31(15):1972-1975. doi: 10.1080/14767058.2017.1333096. Epub 2017 Jun 6.

    PubMed 28585458

  • Tinelli A, Favilli A, Lasmar RB, Mazzon I, Gerli S, Xue X, Malvasi A. The importance of pseudocapsule preservation during hysteroscopic myomectomy. Eur J Obstet Gynecol Reprod Biol. 2019 Dec;243:179-184. doi: 10.1016/j.ejogrb.2019.09.008. Epub 2019 Sep 17.

    PubMed 31585677

  • Tinelli A, Malvasi A, Hurst BS, Tsin DA, Davila F, Dominguez G, Dell'edera D, Cavallotti C, Negro R, Gustapane S, Teigland CM, Mettler L. Surgical management of neurovascular bundle in uterine fibroid pseudocapsule. JSLS. 2012 Jan-Mar;16(1):119-29. doi: 10.4293/108680812X13291597716302.

    PubMed 22906340

  • Tinelli A, Mettler L, Malvasi A, Hurst B, Catherino W, Mynbaev OA, Guido M, Alkatout I, Schollmeyer T. Impact of surgical approach on blood loss during intracapsular myomectomy. Minim Invasive Ther Allied Technol. 2014 Mar;23(2):87-95. doi: 10.3109/13645706.2013.839951. Epub 2013 Sep 18.

    PubMed 24044380

  • Mettler L, Schollmeyer T, Tinelli A, Malvasi A, Alkatout I. Complications of Uterine Fibroids and Their Management, Surgical Management of Fibroids, Laparoscopy and Hysteroscopy versus Hysterectomy, Haemorrhage, Adhesions, and Complications. Obstet Gynecol Int. 2012;2012:791248. doi: 10.1155/2012/791248. Epub 2012 Apr 9.

    PubMed 22619681

  • Tinelli A, Malvasi A, Hudelist G, Cavallotti C, Tsin DA, Schollmeyer T, Bojahr B, Mettler L. Laparoscopic intracapsular myomectomy: comparison of single versus multiple fibroids removal. An institutional experience. J Laparoendosc Adv Surg Tech A. 2010 Oct;20(8):705-11. doi: 10.1089/lap.2010.0082.

    PubMed 20701546

Questions about this trial

What is this clinical trial studying?

An observational study of Uterine Fibroid and Pregnancy Complications, run by Centro di Ricerca Clinica Salentino at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pregnancy complications (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06474065, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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