An interventional study of Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head. in Incision, Surgical, Cesarean Delivery Affecting Fetus and Pfannenstiel Incision Length, sponsored by Near East University, Turkey. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-01.
Sponsored by Near East University, Turkey · Not applicable, Interventional, and Treatment
The purpose of the study is whether the Pfannenstiel skin incision can be adjusted according to the occipitofrontal diameter (OFD) of the fetal head.
Eligable nulliparous women delivered at term by elective cesarean section in which Pfannenstiel skin incision was performed according to the occipitofrontal diameter (OFD) of the fetal head were included. Non-vertex presentaions, all emergency cesarean sections, severe preclampsia, women in active phase of the first stage of labor and second stage of labor, placenta pervia and low lying placenta, multiple pregnancies, uncontrolled gestational diabetes mellitus were excluded.
519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.
This study's enrollment of 115 is above the median of 80 across 412 interventional studies indexed under Surgical Wound.
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Exclusion Criteria:
Pfannenstiel incision performed according to the occipitofrontal diameter of the fetal head
Procedure: Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head.
All women will be subjected to regional spinal anesthesia. Pfannenstiel incision will be made according to the fetal occiputofrontal diameter, marked on the skin (Pfannenstiel incison with Kaya modification) Following blunt entry to the abdominal cavity, the uterine lower segment Kerr incision will be performed. Folllowing delivery of the baby, umblical cord will be cut and an arterial umblical cord blood sample will be taken. Placenta will be removed. 1st and 5th min. Apgar scores will be noted. Uterine incison will be sutured double-layer with 1 polyglactin 910 suture . Peritoneum and fascia, will be closed with 2-0 and 1 polyglactin 910 suture respectively. Skin incision will be sutured with continuous 3-0 rapid polyglactin 910 suture and measured with flexible ruler in centimeters following completing the skin incision closure.
Final Pfannenstiel incision length
Pfannenstiel skin incision length measured as milimetre (mm) which was performed according to the fetal occipitofrontal diameter measured with ultrasonography before delivery
Time frame: up to 48 months
difference between the initial and the Pfannenstiel incision length
difference between the initial incision which was adjusted according to the fetal occipitofrontal diameter and the final Pfannenstiel incision in millimetre(mm)
Time frame: up to 48 months
rate of extension of the Pfannensitel skin incision in the study population
percentage of patients who need of extension of the Pfannensitel skin incision in which the novel technique was performed
Time frame: up to 48 months
duration of cesarean delivery
duration of surgery starts with from the skin incision ends with closing the skin measured with minute
Time frame: up to 48 months
time interval between uterine incision and fetal delivery
time interval between starting the Kerr uterine incision and delivery of the fetus measured with seconds
Time frame: up to 48 months
cut of the abdominal rectus muscle during delivery of the fetus
number of participants who need cut of the abdominal rectus muscle during delivery of the fetus
Time frame: up to 48 months
health evaluation of the newborn with Apgar scoring system
evaluation of the of the health of the newborn with 1. min and 5. min Apgar scoring system (1-10)
Time frame: up to 48 months
evaluation of the fetal acidosis by measuring the umbilical blood ph levels
evaluation of fetal acidosis with umbilical ph values (7.15-7.49), \< 7.1 is accepted as fetal acidosis
Time frame: up to 48 months
Plan to share: No — we may share our data upon request
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Near East University, Turkey