Pregnancy Outcomes Following Myomectomy

AIMS:

• To investigate pregnancy outcomes in relation to surgical approach used for myomectomy.
• 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

• 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]

Exclusion criteria

• 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

DATA TO COLLECT:

• age
• years after myomectomy or CS(for group C)
• gravidity
• parity
• BMI
• myoma characteristics (size and type)
• myomectomy procedure
• gestational week at delivery
• primary indication for CS
• fetal position
• placental pathology
• preoperative hematologic values
• postoperative hematologic values
• duration of the CS
• myoma recurrence in groups A and B
• uterine rupture
• perioperative transfusion
• febrile morbidity
• postoperative hospitalization in days
• PPH
• cause of PPH
• uterine atony
• relaparotomy
• hysterectomy
• blood vessels ligation
• fetal presentation: cephalic/other
• neonatal body weight
• Apgar score

OUTCOMES:

• pregnancy complications

• placental pathology: placenta previa, placental abruption, PAS
• PPROM (gestational age)
• abnormal presentation: cephalic/other
• uterine rupture: complete/incomplete
• preterm/term delivery (gestational age at delivery)
• intraoperative complications

• intraabdominal adhesions/PAI score
• surgery complications: Claven Dindo classification
• other complications:

• neonatal outcome,
• duration of maternal hospitalization,
• primary or secondary PPH
• primary or secondary PPH
• relaparotomy
• peripartum hysterectomy,
• 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.

Inclusion criteria

• 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]

Exclusion criteria

• 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