Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy

Study Overview
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Brief Summary
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The present study aims to investigate whether there is a difference in short- and long-term complications in patients undergoing cesarean myomectomy (endometrial or serosal myomectomy) during cesarean section.

Detailed Description
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Myomectomy is frequently performed during cesarean section. Infertility, myoma recurrence, adhesions , uterine rupture (complete/incomplete), impaired uterine healing (partial or complete dehiscence/poor/good), placental abnormalities, and perinatal complications in subsequent pregnancy are may be associated with cesarean myomectomy. In this study, patients who underwent cesarean myomectomy during cesarean section in our institute were analyzed in a retrospective manner. Patients were divided into three groups as those receiving serosal myomectomy, endometrial myomectomy and those who only underwent cesarean section. The groups were compared with respect to the presence of adhesion formation, time to achieve pregnancy (fertility), morphology of the myomectomy scar, presence of uterine rupture and placental abnormalities.

Official Title
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Long Term Obstetric, Perinatal and Surgical Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Procedure: Cesarean section with cesarean myomectomy (serosal)
* Procedure: Cesarean section without myomectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants should have singleton pregnancy delivered by cesarean section Cesarean section technique should include: Transverse hysterotomy to enter the uterine cavity, single layer closure of the uterine wall, non-sutured visceral and parietal peritoneum Myomectomy during cesarean section should include: only patients, who have undergone a single myomectomy and have been applied a single layer suture technique with the preservation of the pseudocapsule-for all cesarean myomectomy cases Exclusion Criteria: Patients having history of any malignancy Patients with coagulation disorders Patients with a history of previous intraabdominal surgery on reproductive organs Patients with a history of endometriosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serosal myomectomy<br>Patients with singleton pregnancy, who had serosal myomectomy during cesarean section | Procedure: Cesarean section with cesarean myomectomy (serosal)<br>* Serosal or endometrial myomectomy performed during cesarean section<br>* Other names: Cesarean section with cesarean myomectomy (endometrial);|
| Experimental: Endometrial myomectomy<br>Patients with singleton pregnancy, who had endometrial myomectomy during cesarean section | Procedure: Cesarean section with cesarean myomectomy (serosal)<br>* Serosal or endometrial myomectomy performed during cesarean section<br>* Other names: Cesarean section with cesarean myomectomy (endometrial);|
| Placebo Comparator: Control group<br>Patients with singleton pregnancy, who did not have myomectomy during cesarean section | Procedure: Cesarean section without myomectomy<br>* Cesarean delivery without performing myoemctomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of cesarean myomectomy | The difference in the rate of complications associated with the cesarean myomectomy (presence of adhesion formation, time to achieve pregnancy (fertility), morphology of the myomectomy scar, presence of uterine rupture and placental abnormalities) in patients undergoing endometrial myomectomy, serosal myomectomy, or not receiving myomectomy during cesarean section | Post-cesarean 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, Cesarean myomectomy