Clinical trial NCT05632796: Tailored Pfannenstiel Incision for Caesarean Delivery According to the Fetal Head Occipitofrontal Diameter
Official title: Can the Length of the Pfannenstiel Skin Incision be Adjusted According to the Fetal Head During Elective/Planned Cesarean Delivery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incision, Surgical
Cesarean Delivery Affecting Fetus
Pfannenstiel Incision Length
Fetal Occipitofrontal Diameter
Keywords: cesarean delivery
Pfannenstiel incision length
occipitofrontal diameter
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is whether the Pfannenstiel skin incision can be adjusted according to the occipitofrontal diameter (OFD) of the fetal head.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* The women older than 18 years
* term nulliparous pregnancies (\>37w)
* primary elective/planned Cesarean delivery
* fetuses with vertex presentations
* underwent spinal anesthesia

Exclusion Criteria:

* all emergency cesarean sections ( fetal distress, third trimester bleeding including abruption of placenta and placenta previa bleeding, arrest of labor in the second phase)
* cesarean delivery for severe preeclampsia
* cesarean delivery for non-vertex fetal presentations (breech and shoulder presentation)
* cesarean delivery for deflexion fetal head presentations (face and brow)
* cesarean delivery during active phase of the first stage of labor
* cesarean delivery for placenta previa or low-lying placenta,
* cesarean delivery for multiple pregnancies
* all cesarean deliveries with uncontrolled gestational or non-gestational diabetes mellitus

Primary outcomes:
measure: Final Pfannenstiel incision length
timeFrame: up to 48 months
measure: difference between the initial and the Pfannenstiel incision length
timeFrame: up to 48 months
measure: rate of extension of the Pfannensitel skin incision in the study population
timeFrame: up to 48 months
Secondary outcomes:
measure: duration of cesarean delivery
timeFrame: up to 48 months
measure: time interval between uterine incision and fetal delivery
timeFrame: up to 48 months
measure: cut of the abdominal rectus muscle during delivery of the fetus
timeFrame: up to 48 months
measure: health evaluation of the newborn with Apgar scoring system
timeFrame: up to 48 months
measure: evaluation of the fetal acidosis by measuring the umbilical blood ph levels
timeFrame: up to 48 months
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Near East University, Obstetrics and Gynecology
state: Trnc
Study officials:
affiliation: Near East University Faculty of Medicine, Lefkosa-10 TRNC, Mersin, Turkey
name: baris kaya, Assos.Prof
role: PRINCIPAL_INVESTIGATOR
References: