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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Zeynep Kamil Maternity and Childrens Training and Research Hospital

    Istanbul, Uskudar, 34668

    Resul Karakus, MD, 05059164216, resul-karakus@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

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 groups in NCT04891042
Study groupRoleWhat they receive
Latent Phase of LabourNot described
Active Phase of LabourNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted18 May 2021
  2. Study start1 Feb 2021
  3. Primary completion2 May 2021
  4. Study completion2 Dec 2021 (estimated)

Resources

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)
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

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.

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