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Tailored Pfannenstiel Incision for Caesarean Delivery According to the Fetal Head Occipitofrontal Diameter

Can the Length of the Pfannenstiel Skin Incision be Adjusted According to the Fetal Head During Elective/Planned Cesarean Delivery?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05632796
Enrollment
115
Registered
2022-12-01
Start date
2017-06-01
Completion date
2021-10-01
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Delivery Affecting Fetus, Fetal Occipitofrontal Diameter, Incision, Surgical, Pfannenstiel Incision Length

Keywords

cesarean delivery, Pfannenstiel incision length, occipitofrontal diameter

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.

Interventions

PROCEDUREAdjusting 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.

Sponsors

Near East University, Turkey
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Final Pfannenstiel incision lengthup to 48 monthsPfannenstiel skin incision length measured as milimetre (mm) which was performed according to the fetal occipitofrontal diameter measured with ultrasonography before delivery
difference between the initial and the Pfannenstiel incision lengthup to 48 monthsdifference between the initial incision which was adjusted according to the fetal occipitofrontal diameter and the final Pfannenstiel incision in millimetre(mm)
rate of extension of the Pfannensitel skin incision in the study populationup to 48 monthspercentage of patients who need of extension of the Pfannensitel skin incision in which the novel technique was performed

Secondary

MeasureTime frameDescription
health evaluation of the newborn with Apgar scoring systemup to 48 monthsevaluation of the of the health of the newborn with 1. min and 5. min Apgar scoring system (1-10)
duration of cesarean deliveryup to 48 monthsduration of surgery starts with from the skin incision ends with closing the skin measured with minute
evaluation of the fetal acidosis by measuring the umbilical blood ph levelsup to 48 monthsevaluation of fetal acidosis with umbilical ph values (7.15-7.49), \< 7.1 is accepted as fetal acidosis
time interval between uterine incision and fetal deliveryup to 48 monthstime interval between starting the Kerr uterine incision and delivery of the fetus measured with seconds
cut of the abdominal rectus muscle during delivery of the fetusup to 48 monthsnumber of participants who need cut of the abdominal rectus muscle during delivery of the fetus

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026