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

NCT ID: NCT05632796

Last Updated: 2022-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2021-10-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tailored pfannenstiel incision according to the fetal head OFD

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Near East University, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Baris KAYA

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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baris kaya, Assos.Prof

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Near East University, Obstetrics and Gynecology

Mersin, TRNC, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 37829600 (View on PubMed)

Other Identifiers

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Cesarean incision-1398

Identifier Type: -

Identifier Source: org_study_id

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