Incision, SurgicalNCT05632796
Tailored Pfannenstiel Incision for Caesarean Delivery According to the Fetal Head Occipitofrontal Diameter
A study testing Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head. in people with Incision, Surgical and Cesarean Delivery Affecting Fetus, run by Near East University, Turkey at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incision, Surgical, Cesarean Delivery Affecting Fetus, Pfannenstiel Incision Length
- What is being tested?
- Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2017to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The women older than 18 years
- term nulliparous pregnancies (>37w)
- primary elective/planned Cesarean delivery
- fetuses with vertex presentations
- underwent spinal anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Near East University, Obstetrics and Gynecology
Mersin, TRNC, 10
About this study
Official title: 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.
Read the 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.
- Conditions
- Incision, Surgical, Cesarean Delivery Affecting Fetus, Pfannenstiel Incision Length, Fetal Occipitofrontal Diameter
- Being tested
- Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head.
- Keywords
- cesarean delivery, Pfannenstiel incision length, occipitofrontal diameter
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| tailored pfannenstiel incision according to the fetal head OFD | Experimental | Pfannenstiel incision performed according to the occipitofrontal diameter of the fetal head Receives: Procedure: Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: up to 48 months
Secondary outcomes (5)
duration of cesarean delivery
duration of surgery starts with from the skin incision ends with closing the skin measured with minute
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Jun 2017
- Primary completion30 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incision, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baris KAYA, Near East University, Turkey
- Investigators
- baris kaya, Assos.Prof, Principal investigator, Near East University Faculty of Medicine, Lefkosa-10 TRNC, Mersin, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632796
- Sponsor's protocol ID
- Cesarean incision-1398
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we may share our data upon request
Publications
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.
PubMed 37829600
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Length of the Pfannenstiel Skin Incision be Adjusted According to the Fetal Head During Elective/Planned Cesarean Delivery?
- ClinicalTrials.gov ID
- NCT05632796
- Acronym / sponsor ID
- Cesarean incision-1398
- Conditions
- Incision, Surgical, Cesarean Delivery Affecting Fetus, Pfannenstiel Incision Length, Fetal Occipitofrontal Diameter
- Keywords
- cesarean delivery, Pfannenstiel incision length, occipitofrontal diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tailored pfannenstiel incision according to the fetal head OFD | Experimental | Procedure: Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head.Pfannenstiel incision performed according to the occipitofrontal diameter of the fetal head |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The women older than 18 years
- term nulliparous pregnancies (>37w)
- primary elective/planned Cesarean delivery
- fetuses with vertex presentations
- underwent spinal anesthesia
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | tailored pfannenstiel incision according to the fetal head OFD |
Primary outcome
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
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)
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
5 secondary outcomes
duration of cesarean delivery
Time frame: up to 48 months
time interval between uterine incision and fetal delivery
Time frame: up to 48 months
cut of the abdominal rectus muscle during delivery of the fetus
Time frame: up to 48 months
health evaluation of the newborn with Apgar scoring system
Time frame: up to 48 months
evaluation of the fetal acidosis by measuring the umbilical blood ph levels
Time frame: up to 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Derived from this study: PubMed 37829600Kaya 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.
- Individual participant dataSharing planned: No. we may share our data upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
baris kaya, Assos.Prof principal investigator
Near East University Faculty of Medicine, Lefkosa-10 TRNC, Mersin, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjusting the Pfannenstiel skin incision according to the occipitofrontal diameter (OFD) of the fetal head. in people with Incision, Surgical and Cesarean Delivery Affecting Fetus, run by Near East University, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final Pfannenstiel incision length (time frame: up to 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05632796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.