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?

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

Study Overview

• Status: Completed
• Conditions: Cesarean Delivery Affecting Fetus; Incision, Surgical; Pfannenstiel Incision Length; Fetal Occipitofrontal Diameter
• Intervention / Treatment: Procedure: Adjusting the Pfannenstiel skin incision 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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Trnc
    • Mersin, Trnc, Turkey, 10
      • Near East University, Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: tailored pfannenstiel incision according to the fetal head OFD; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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	up to 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of cesarean delivery	duration of surgery starts with from the skin incision ends with closing the skin measured with minute	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	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	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)	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	up to 48 months

Collaborators and Investigators

• Sponsor: Near East University, Turkey
• Investigators: Principal Investigator: baris kaya, Assos.Prof, Near East University Faculty of Medicine, Lefkosa-10 TRNC, Mersin, Turkey

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (ACTUAL): December 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: cesarean delivery; Pfannenstiel incision length; occipitofrontal diameter
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: Cesarean incision-1398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: we may share our data upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No