Pregnancy Outcomes Following Myomectomy

NCT06474065 | Completed DMC

• 1 other identifier: CER 0324
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Reproductive Sterility; Uterine Fibroid; Pregnancy Complications; Reproductive Issues

Keywords

Fibroids; Leiomyoma; Myomectomy; Outcome; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Pregnancy complications

  placental pathology, intraoperative complications, other complications

  1 year

Secondary Outcomes (1)

• Intraoperative complications

  1 year

Other Outcomes (1)

• other complications

  1 year

Study Arms (2)

Treated patiens' Group as Group 1

Patients submitted to hysteroscopic, laparoscopic or laparotomic myomectomy

Procedure: Myomectomy

Untreated patiens' Group as Group 2

Control group - unoperated patients

Interventions

Myomectomy PROCEDURE

Patients submitted to operation of fibroids removal

Treated patiens' Group as Group 1

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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 \[group C\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro di Ricerca Clinica Salentino: lead

Study Sites (1)

Andrea Tinelli

Lecce, Le, 73100, Italy

Location

Related Publications (13)

• 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.

  PMID: 32064967 RESULT

• 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.

  PMID: 38674255 RESULT

• 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.

  PMID: 28114870 RESULT

• 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.

  PMID: 37450263 RESULT

• 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.

  PMID: 22095838 RESULT

• 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.

  PMID: 30700185 RESULT

• 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.

  PMID: 23662726 RESULT

• 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.

  PMID: 28585458 RESULT

• 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.

  PMID: 31585677 RESULT

• 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.

  PMID: 22906340 RESULT

• 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.

  PMID: 24044380 RESULT

• 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.

  PMID: 22619681 RESULT

• 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.

  PMID: 20701546 RESULT

MeSH Terms

Conditions

Leiomyoma; Pregnancy Complications; Infertility

Interventions

Uterine Myomectomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Andrea Tinelli, MD

  Centro di Ricerca Clinica Salentino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: June 28, 2024
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year
• Access Criteria: I'm considering to make IPD Sharing Access Criteria

Locations

IT (1)