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

Not Applicable

Completed

• Conditions: Incision, Surgical; Pfannenstiel Incision Length; Fetal Occipitofrontal Diameter; Cesarean Delivery Affecting Fetus
• Interventions: Procedure: Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head.

• Registration Number: NCT05632796
• Lead Sponsor: Near East University, Turkey

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.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Study First Posted: 2022-12-01
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tailored pfannenstiel incision according to the fetal head OFD	Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head.	Pfannenstiel incision performed according to the occipitofrontal diameter of the fetal head

Primary Outcome Measures

Name	Time	Method
difference between the initial and the Pfannenstiel incision length	up to 48 months	difference between the initial incision which was adjusted according to the fetal occipitofrontal diameter and the final Pfannenstiel incision in millimetre(mm)
Final Pfannenstiel incision length	up to 48 months	Pfannenstiel skin incision length measured as milimetre (mm) which was performed according to the fetal occipitofrontal diameter measured with ultrasonography before delivery
rate of extension of the Pfannensitel skin incision in the study population	up to 48 months	percentage of patients who need of extension of the Pfannensitel skin incision in which the novel technique was performed

Secondary Outcome Measures

Name	Time	Method
duration of cesarean delivery	up to 48 months	duration of surgery starts with from the skin incision ends with closing the skin measured with minute
time interval between uterine incision and fetal delivery	up to 48 months	time interval between starting the Kerr uterine incision and delivery of the fetus measured with seconds
evaluation of the fetal acidosis by measuring the umbilical blood ph levels	up to 48 months	evaluation of fetal acidosis with umbilical ph values (7.15-7.49), \< 7.1 is accepted as fetal acidosis
cut of the abdominal rectus muscle during delivery of the fetus	up to 48 months	number of participants who need cut of the abdominal rectus muscle during delivery of the fetus
health evaluation of the newborn with Apgar scoring system	up to 48 months	evaluation of the of the health of the newborn with 1. min and 5. min Apgar scoring system (1-10)

Trial Locations

Locations (1)

Near East University, Obstetrics and Gynecology; 🇹🇷 Mersin, Trnc, Turkey