Cesarean Section ComplicationsNCT04766567
Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy
A study testing Cesarean section with cesarean myomectomy (serosal) and Cesarean section without myomectomy in people with Cesarean Section Complications, run by Bilge Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Cesarean section with cesarean myomectomy (serosal) and Cesarean section without myomectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Obstetric, Perinatal and Surgical Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy
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.
Read the detailed description
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.
- Conditions
- Cesarean Section Complications
- Being tested
- Cesarean section with cesarean myomectomy (serosal), Cesarean section without myomectomy
- Keywords
- Cesarean section, Cesarean myomectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean section with cesarean myomectomy (serosal)Procedure or surgery
Also called Cesarean section with cesarean myomectomy (endometrial)
Serosal or endometrial myomectomy performed during cesarean section
Cesarean section without myomectomyProcedure or surgery
Cesarean delivery without performing myoemctomy
| Study group | Role | What they receive |
|---|---|---|
| Serosal myomectomy | Experimental | Patients with singleton pregnancy, who had serosal myomectomy during cesarean section Receives: Procedure: Cesarean section with cesarean myomectomy (serosal) |
| Endometrial myomectomy | Experimental | Patients with singleton pregnancy, who had endometrial myomectomy during cesarean section Receives: Procedure: Cesarean section with cesarean myomectomy (serosal) |
| Control group | Placebo comparator | Patients with singleton pregnancy, who did not have myomectomy during cesarean section Receives: Procedure: Cesarean section without myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post-cesarean 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start15 Jun 2020
- Primary completion15 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilge Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Guler, Bilge Hospital
- Investigators
- Oguz Guler, M.D., Principal investigator, Bilge Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766567
- Sponsor's protocol ID
- 1
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Obstetric, Perinatal and Surgical Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy
- ClinicalTrials.gov ID
- NCT04766567
- Acronym / sponsor ID
- 1
- Conditions
- Cesarean Section Complications
- Keywords
- Cesarean section, Cesarean myomectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bilge HospitalUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Serosal myomectomy | Experimental | Procedure: Cesarean section with cesarean myomectomy (serosal)Patients with singleton pregnancy, who had serosal myomectomy during cesarean section |
| Endometrial myomectomy | Experimental | Procedure: Cesarean section with cesarean myomectomy (serosal)Patients with singleton pregnancy, who had endometrial myomectomy during cesarean section |
| Control group | Placebo comparator | Procedure: Cesarean section without myomectomyPatients with singleton pregnancy, who did not have myomectomy during cesarean section |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cesarean section with cesarean myomectomy (serosal)Also: Cesarean section with cesarean myomectomy (endometrial)Serosal or endometrial myomectomy performed during cesarean section | Procedure or surgery | Endometrial myomectomy, Serosal myomectomy |
| Cesarean section without myomectomyCesarean delivery without performing myoemctomy | Procedure or surgery | Control group |
Primary outcome
Complications of cesarean myomectomy
Time frame: Post-cesarean 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oguz Guler, M.D. principal investigator
Bilge Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cesarean section with cesarean myomectomy (serosal) and Cesarean section without myomectomy in people with Cesarean Section Complications, run by Bilge Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications of cesarean myomectomy (time frame: Post-cesarean 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.