Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474065
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-19
Brief Title:
Pregnancy Outcomes Following Myomectomy
Sponsor:
Centro di Ricerca Clinica Salentino
Organization:
Centro di Ricerca Clinica Salentino
Study Overview
Official Title:
Pregnancy Outcomes Following Hysteroscopic Laparoscopic and Laparotomic Myomectomy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 BCS 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 hysteroscopiclaparoscopiclaparotomic 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 CSfor 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 cephalicother
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 cephalicother
4 uterine rupture completeincomplete
5 pretermterm delivery gestational age at delivery
2 intraoperative complications
1 intraabdominal adhesionsPAI 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
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 BCS 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 hysteroscopiclaparoscopiclaparotomic 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 CSfor 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 cephalicother
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 cephalicother
4 uterine rupture completeincomplete
5 pretermterm delivery gestational age at delivery
2 intraoperative complications
1 intraabdominal adhesionsPAI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None