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Completed

NCT Number: NCT05632796

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

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

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Key information

Conditions

Incision, Surgical Cesarean Delivery Affecting Fetus Fetal Occipitofrontal Diameter Pfannenstiel Incision Length Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Near East University, Obstetrics and Gynecology

Mersin, TRNC, 10, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Final Pfannenstiel incision length

    Time frame: 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

  2. difference between the initial and the Pfannenstiel incision length

    Time frame: 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)

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

    Time frame: up to 48 months

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

Secondary outcomes

  1. duration of cesarean delivery

    Time frame: up to 48 months

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

  2. time interval between uterine incision and fetal delivery

    Time frame: up to 48 months

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

  3. cut of the abdominal rectus muscle during delivery of the fetus

    Time frame: up to 48 months

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

  4. health evaluation of the newborn with Apgar scoring system

    Time frame: up to 48 months

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

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

    Time frame: up to 48 months

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

Sponsors and collaborators

Lead sponsor

Near East University, Turkey

Other

Registry information

Official study title

Can the Length of the Pfannenstiel Skin Incision be Adjusted According to the Fetal Head During Elective/Planned Cesarean Delivery?

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2022
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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