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Completed

NCT Number: NCT02479932

A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section

The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk Üniversitesi Araştırma Hastanesi

Erzurum, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • elective cesarean
  • previous cesarean (<4)
  • cesarean for distocia

Exclusion criteria

  • emergency cesarean ( fetal distress)
  • risk of obstetrical bleeding
  • maternal coagulation defects
  • adnexial mass
  • uterin myoma at incision site

Treatment and study plan

Transperitoneal cesarean technique

Other

Pfannenstiel-Kerr technique for laparatomy and uterine entry

Extraperitoneal cesarean technique

Other

Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry

Primary outcomes

  1. Skin-to-delivery time

    Time frame: 1 minute after delivery

Secondary outcomes

  1. Postoperative pain

    Time frame: 24 and 48 hour after cesarean

    Pain will be measured by VAS

  2. Operation time

    Time frame: Two minutes after surgery

    skin-to-skin operation time

  3. Hemoglobin differences

    Time frame: One hour before cesarean and 48 hours after cesarean

  4. Need for analgesic

    Time frame: 24 and 48 hours after cesarean

    All analgesic given after cesarean at hospital

  5. Nausea

    Time frame: Two minutes and 48 hours after cesarean

    Nausea during surgery and after surgery

  6. Vomiting

    Time frame: Two minutes and 48 hours after cesarean

    Nausea during and after surgery

  7. Thoracic shoulder pain

    Time frame: 48 hours after cesarean

    Thoracic shoulder pain after surgery

  8. Urogenital distress measured by Urogenital Distress Inventory

    Time frame: One hour before cesarean and 24 hours after cesarean

  9. Oral intake

    Time frame: 12 and 24 hours postoperatively

    The percentage of patients who tolerates oral intake. Oral intake will be allowed 4-6 hours after cesarean for extraperitoneal group. For intraperitoneal group it will be allowed when patient passed gas.

  10. Anxiety during surgery

    Time frame: One minute after cesarean

    Intense fear or anxiety during surgery without pain (yes or no)

  11. Pain during surgery

    Time frame: One minutes after surgery

    Abdominal pain during surgery (yes or no)

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

A Comparison of Skin to Delivery Time at Exztraperitoneal vs. Transpirational Cesarean

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2015
Registry last updated
Mar 15, 2016

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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