Clinical trial · Observational
Pregnancy Outcomes Following Myomectomy
Pregnancy Outcomes Following Hysteroscopic, Laparoscopic and Laparotomic Myomectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pregnancy Complications | — | UNRESOLVED | — |
| Reproductive Issues | — | UNRESOLVED | — |
| Reproductive Sterility | — | UNRESOLVED | — |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Myomectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Treated patiens' Group as Group 1
- description
- Patients submitted to hysteroscopic, laparoscopic or laparotomic myomectomy
- interventionNames
- Procedure: Myomectomy
- label
- Untreated patiens' Group as Group 2
- description
- Control group - unoperated patients
Primary outcomes (1)
- measure
- Pregnancy complications
- timeFrame
- 1 year
- description
- placental pathology, intraoperative complications, other complications
Secondary outcomes (1)
- measure
- Intraoperative complications
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (13)
- RESULTHatirnaz 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
- RESULTSparic 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
- RESULTHatirnaz 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
- RESULTTinelli 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
- RESULTTinelli 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
- RESULTSparic 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.