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

Primary Purpose

Incision, Surgical, Cesarean Delivery Affecting Fetus, Pfannenstiel Incision Length

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Incision, Surgical focused on measuring cesarean delivery, Pfannenstiel incision length, occipitofrontal diameter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Near East University, Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tailored pfannenstiel incision according to the fetal head OFD

Arm Description

Pfannenstiel incision performed according to the occipitofrontal diameter of the fetal head

Outcomes

Primary Outcome Measures

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

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)

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

Secondary Outcome Measures

duration of cesarean delivery

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

time 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 fetus

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

evaluation of the of the health of the newborn with 1. min and 5. min Apgar scoring system (1-10)

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

Full Information

NCT ID

NCT05632796

First Posted

November 14, 2022

Last Updated

November 21, 2022

Sponsor

Near East University, Turkey

1. Study Identification

Unique Protocol Identification Number

NCT05632796

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

September 30, 2021 (Actual)

Study Completion Date

October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Near East University, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

cesarean delivery, Pfannenstiel incision length, occipitofrontal diameter

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tailored pfannenstiel incision according to the fetal head OFD

Arm Type

Experimental

Arm Description

Pfannenstiel incision performed according to the occipitofrontal diameter of the fetal head

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Final Pfannenstiel incision length

Description

Pfannenstiel skin incision length measured as milimetre (mm) which was performed according to the fetal occipitofrontal diameter measured with ultrasonography before delivery

Time Frame

up to 48 months

Title

difference between the initial and the Pfannenstiel incision length

Description

difference between the initial incision which was adjusted according to the fetal occipitofrontal diameter and the final Pfannenstiel incision in millimetre(mm)

Time Frame

up to 48 months

Title

rate of extension of the Pfannensitel skin incision in the study population

Description

percentage of patients who need of extension of the Pfannensitel skin incision in which the novel technique was performed

Time Frame

up to 48 months

Secondary Outcome Measure Information:

Title

duration of cesarean delivery

Description

duration of surgery starts with from the skin incision ends with closing the skin measured with minute

Time Frame

up to 48 months

Title

time interval between uterine incision and fetal delivery

Description

time interval between starting the Kerr uterine incision and delivery of the fetus measured with seconds

Time Frame

up to 48 months

Title

cut of the abdominal rectus muscle during delivery of the fetus

Description

number of participants who need cut of the abdominal rectus muscle during delivery of the fetus

Time Frame

up to 48 months

Title

health evaluation of the newborn with Apgar scoring system

Description

evaluation of the of the health of the newborn with 1. min and 5. min Apgar scoring system (1-10)

Time Frame

up to 48 months

Title

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

Description

evaluation of fetal acidosis with umbilical ph values (7.15-7.49), < 7.1 is accepted as fetal acidosis

Time Frame

up to 48 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

pregnant women

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

baris kaya, Assos.Prof

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Near East University, Obstetrics and Gynecology

City

Mersin

State/Province

Trnc

ZIP/Postal Code

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

we may share our data upon request

Learn more about this trial

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

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