Clinical trial NCT06474065: Pregnancy Outcomes Following Myomectomy
Official title: Pregnancy Outcomes Following Hysteroscopic, Laparoscopic and Laparotomic Myomectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Fibroid
Pregnancy Complications
Reproductive Issues
Reproductive Sterility
Keywords: Fibroids
Leiomyoma
Myomectomy
Outcome
Pregnancy
Lead sponsor: Centro di Ricerca Clinica Salentino
Sponsor class: NETWORK
First posted: 2024-06-25
Enrollment: 150
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy complications
timeFrame: 1 year
Secondary outcomes:
measure: Intraoperative complications
timeFrame: 1 year
Other outcomes:
measure: other complications
timeFrame: 1 year
Locations:
city: Lecce
country: Italy
facility: Andrea Tinelli
state: Le
Study officials:
affiliation: Centro di Ricerca Clinica Salentino
name: Andrea Tinelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.