Uterus; ScarIsthmoceleNCT04891042
Isthmocele Development Due to Primary Cesarean Section at The Latent or Active Phase
An observational study of Uterus; Scar, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The importance of isthmocele development due to primary cesarean section at the latent or active phase of labour Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Uterus; Scar
- How many people
- 320 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 2 Dec 2021
- Phase
- Observational
- 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 45 years
- Women only
- Adult
Study population: Pregnant Patients at the age of minimum 18 to 45 and with the gestational weeks between 32 to 41, with no history of caesarean section and no confirmed placenta previa and/or invasion anomaly
Who may be able to join
- Pregnant women with the gestational weeks between 32-41 primigravida or multigravida with no history of caesarean section
Who cannot join
- Gestational age below 32 weeks
- Confirmed Plasenta Previa and/or placental invasion anomalies
- A history Caeserean Section
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zeynep Kamil Maternity and Childrens Training and Research Hospital
Istanbul, Uskudar, 34668
Resul Karakus, MD, 05059164216, resul-karakus@hotmail.com
About this study
Official title: The Importance of Isthmocele Development Due to Primary Cesarean Section at The Latent or Active Phase of Labour
The importance of isthmocele development due to primary cesarean section at the latent or active phase of labour
Read the detailed description
The dates between February 2021 to December 2021 , primiparous (primigravida) and multiparous (multigravida) patients who were hospitalized for delivery between 32 and 41 weeks of gestation and who haven't received cesarean in their previous delivery will be included in the study in Zeynep Kamil Training and Research Hospital Hynecology and Obstetrics Clinic. These patients who will have indication for primary cesarean section will be divided into two groups as latent and active phase according to cervical opening and effacement.During cesarean section , tue uterine lower segment transverse incision will be continuously sutured with 1.0 vicryl( with no interlocking). Also the visceral peritoneum of the vesicle-uterine cavity will be sutured with 2.0 vicryl, This closure technique is to provide hemostasis in the incision. Also additional single interrupted sutures will be recorded(on the each side and /or in the middle of incision).Also If additional surgical interventions such as vessel ligation, uterine artery compression sutures ( such as B-Lynch) will be performed during the surgery, the will be recorded.In this study, If the patients with gestational age below 32, confirmed placenta previa or invasion anomaly and a history of previous cesarean section will not be included.All patient's age, gravid , parity, height, weight, gestational week, smoking history, chronic disease such as hypertension, diabetes mellitus, obstetric history such as oligo-polihidroamnios, abortus imminent,etc previous abdominal surgeries, drug use, use of dinoprost(process) for cervical effacement, cervical Foley catheter use, use of oxytocin, duration of labor, presence of early membrane rupture, time interval from the beginning of rupture membrane, presentation, indication for cesarean section, cervikal dilatation and effacement just before the cesarean section, duration of the operation, use of additional uterotonics during the surgery, additional sutures for hemostasis, presence of atony, additional surgical interventions( uterine artery and hypogastric artery ligation, uterine compression sutures), birth weight, preoperative and post hemogram, hematocrit, white blood cell count, platelet count, blood transfusion if it was given, discharge time, and endometriosis will be recorded. Patients will be called for control examination in the third( 3rd) month after operation. And patients will be asked about clinical findings such as prolonged menstrual bleeding, midsiklus bleeding, dysmenorrhea, pelvic pain. At the same time the presence of isthmuses, the depth and the shape of the istmosel pocket and the myometrial thickness will be measured and recorded with transvaginal ultrasound. Thus, the importance of isthmocele formation on patients who had caeserean section either on latent phase or active phase of labor will be investigated . In addition , other risk factors leading to isthmocele formation will be investigated.
- Conditions
- Uterus; Scar
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Latent Phase of Labour | Not described | |
| Active Phase of Labour | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isthmocele Development
ISTHMOCELE DEVELOPMENT ACCORDİNG TO CERVİCAL DİLATATİON AND EFFACEMENTS
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Feb 2021
- Primary completion2 May 2021
- Study completion2 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterus; ScarStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Resul Karakuş, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891042
- Sponsor's protocol ID
- 2020/178
- Acronym
- Isthmocele
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 18 May 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 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Isthmocele Development Due to Primary Cesarean Section at The Latent or Active Phase of Labour
- ClinicalTrials.gov ID
- NCT04891042
- Acronym / sponsor ID
- Isthmocele / 2020/178
- Conditions
- Uterus; Scar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 2 Dec 2021 (estimated)
- First posted
- 18 May 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 importance of isthmocele development due to primary cesarean section at the latent or active phase of labour
Detailed description
The dates between February 2021 to December 2021 , primiparous (primigravida) and multiparous (multigravida) patients who were hospitalized for delivery between 32 and 41 weeks of gestation and who haven't received cesarean in their previous delivery will be included in the study in Zeynep Kamil Training and Research Hospital Hynecology and Obstetrics Clinic. These patients who will have indication for primary cesarean section will be divided into two groups as latent and active phase according to cervical opening and effacement.During cesarean section , tue uterine lower segment transverse incision will be continuously sutured with 1.0 vicryl( with no interlocking). Also the visceral peritoneum of the vesicle-uterine cavity will be sutured with 2.0 vicryl, This closure technique is to provide hemostasis in the incision. Also additional single interrupted sutures will be recorded(on the each side and /or in the middle of incision).Also If additional surgical interventions such as vessel ligation, uterine artery compression sutures ( such as B-Lynch) will be performed during the surgery, the will be recorded.In this study, If the patients with gestational age below 32, confirmed placenta previa or invasion anomaly and a history of previous cesarean section will not be included.All patient's age, gravid , parity, height, weight, gestational week, smoking history, chronic disease such as hypertension, diabetes mellitus, obstetric history such as oligo-polihidroamnios, abortus imminent,etc previous abdominal surgeries, drug use, use of dinoprost(process) for cervical effacement, cervical Foley catheter use, use of oxytocin, duration of labor, presence of early membrane rupture, time interval from the beginning of rupture membrane, presentation, indication for cesarean section, cervikal dilatation and effacement just before the cesarean section, duration of the operation, use of additional uterotonics during the surgery, additional sutures for hemostasis, presence of atony, additional surgical interventions( uterine artery and hypogastric artery ligation, uterine compression sutures), birth weight, preoperative and post hemogram, hematocrit, white blood cell count, platelet count, blood transfusion if it was given, discharge time, and endometriosis will be recorded. Patients will be called for control examination in the third( 3rd) month after operation. And patients will be asked about clinical findings such as prolonged menstrual bleeding, midsiklus bleeding, dysmenorrhea, pelvic pain. At the same time the presence of isthmuses, the depth and the shape of the istmosel pocket and the myometrial thickness will be measured and recorded with transvaginal ultrasound. Thus, the importance of isthmocele formation on patients who had caeserean section either on latent phase or active phase of labor will be investigated . In addition , other risk factors leading to isthmocele formation will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latent Phase of Labour | – | – |
| Active Phase of Labour | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant Patients at the age of minimum 18 to 45 and with the gestational weeks between 32 to 41, with no history of caesarean section and no confirmed placenta previa and/or invasion anomaly
Key inclusion criteria (1 listed)
- Pregnant women with the gestational weeks between 32-41 primigravida or multigravida with no history of caesarean section
Key exclusion criteria (3 listed)
- Gestational age below 32 weeks
- Confirmed Plasenta Previa and/or placental invasion anomalies
- A history Caeserean Section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Isthmocele Development
Time frame: 10 months
ISTHMOCELE DEVELOPMENT ACCORDİNG TO CERVİCAL DİLATATİON AND EFFACEMENTS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterus; Scar, run by Zeynep Kamil Maternity and Pediatric Research and Training 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 May 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RESUL KARAKUS, MD (00905059164216, resul-karakus@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isthmocele Development (time frame: 10 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 18 May 2021.