Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04891042 |
| Other study ID # |
2020/178 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
December 2, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Zeynep Kamil Maternity and Pediatric Research and Training Hospital |
| Contact |
RESUL KARAKUS, MD |
| Phone |
00905059164216 |
| Email |
resul-karakus[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The importance of isthmocele development due to primary cesarean section at the latent or
active phase of labour
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.
