Isthmocele Development Due to Primary Cesarean Section at The Latent or Active Phase (Isthmocele)

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

Study Overview

• Status: Recruiting
• Conditions: Uterus; Scar

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 Type: Observational
• Enrollment (Anticipated): 320

Contacts and Locations

• Study Contact: Name: Resul Karakus, MD; Phone Number: 00905059164216; Email: resul-karakus@hotmail.com

Study Locations

• Turkey
  • Uskudar
    • Istanbul, Uskudar, Turkey, 34668
      • Recruiting
      • Zeynep Kamil Maternity and Childrens Training and Research Hospital
      • Contact: Resul Karakus, MD; Phone Number: 05059164216; Email: resul-karakus@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• Pregnant women with the gestational weeks between 32-41 primigravida or multigravida with no history of caesarean section

Exclusion Criteria:

• Gestational age below 32 weeks
• Confirmed Plasenta Previa and/or placental invasion anomalies
• A history Caeserean Section

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Latent Phase of Labour
Active Phase of Labour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isthmocele Development	ISTHMOCELE DEVELOPMENT ACCORDİNG TO CERVİCAL DİLATATİON AND EFFACEMENTS	10 months

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): May 2, 2021
• Study Completion (Anticipated): December 2, 2021

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020/178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No