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

NCT05632796 | Completed

• 1 other identifier: Cesarean incision-1398
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cesarean delivery; Pfannenstiel incision length; occipitofrontal diameter

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• duration of cesarean delivery

  up to 48 months

• time interval between uterine incision and fetal delivery

  up to 48 months

• cut of the abdominal rectus muscle during delivery of the fetus

  up to 48 months

• health evaluation of the newborn with Apgar scoring system

  up to 48 months

• evaluation of the fetal acidosis by measuring the umbilical blood ph levels

  up to 48 months

Study Arms (1)

tailored pfannenstiel incision according to the fetal head OFD

EXPERIMENTAL

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.

Interventions

Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head. PROCEDURE

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.

tailored pfannenstiel incision according to the fetal head OFD

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Near East University, Obstetrics and Gynecology

Mersin, TRNC, 10, Turkey (Türkiye)

Location

Related Publications (1)

• Kaya B, Ozay OE, Ozay AC, Tuten A. Can the Pfannenstiel skin incision length be adjusted according to the fetal head during elective cesarean delivery? Front Surg. 2023 Sep 26;10:1227338. doi: 10.3389/fsurg.2023.1227338. eCollection 2023.

  PMID: 37829600 DERIVED

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• baris kaya, Assos.Prof

  Near East University Faculty of Medicine, Lefkosa-10 TRNC, Mersin, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 1, 2022
• Study Start: June 1, 2017
• Primary Completion: September 30, 2021
• Study Completion: October 1, 2021
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)