Pregnancy Outcomes Following Myomectomy

Centro di Ricerca Clinica Salentino

Status: Enrolling

Conditions: Pregnancy Complications; Uterine Fibroid; Reproductive Issues; Reproductive Sterility

Treatments: Procedure: Myomectomy

Study type: Observational

Funder types: NETWORK; Other

Identifiers

NCT06474065

CER 0324

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Treated patiens' Group as Group 1

Description:

Patients submitted to hysteroscopic, laparoscopic or laparotomic myomectomy

Treatment:

Procedure: Myomectomy

Untreated patiens' Group as Group 2

Description:

Control group - unoperated patients