CompletedNot Applicable

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

Turkey (Türkiye)115 participantsStarted 2017-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Final Pfannenstiel incision length

Timeframe: up to 48 months

difference between the initial and the Pfannenstiel incision length

Timeframe: up to 48 months

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

Timeframe: up to 48 months

Trial details

NCT IDNCT05632796

SponsorNear East University, Turkey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-30

View on ClinicalTrials.gov More Incision, Surgical trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.