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Completed

NCT Number: NCT02155569

Extraperitoneal Versus Transperitoneal Cesarean Section

The aim of the study is to compare post operative morbidity between extra peritoneal cesarian and trans peritoneal cesarean section.

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Key information

Conditions

Cesarean, Extraperitoneal Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University Hospital

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 (primary or repeated up to four)

Exclusion criteria

  • emergent cesarean
  • macrosomia (fetal weight > 4500 g)
  • history of major abdominal surgery
  • suspected abnormal placentation
  • placenta previa

Treatment and study plan

Extraperitoneal Cesarean

Procedure

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

Transperitoneal Cesarean

Procedure

Pfannenstiel-Kerr technique for laparatomy and uterine entry

Primary outcomes

  1. post operative pain

    Time frame: One hour before cesarean and 24 hour postoperatively

    Perceived pain scores will be measured by an visual analog scale.

Secondary outcomes

  1. delivery time

    Time frame: 2 minutes after delivery

    skin incision to delivery

  2. operation time

    Time frame: 5 minutes postoperatively

    skin incision to skin closure

  3. hemoglobin differences

    Time frame: one hour before cesarean, 48 hour postoperatively

  4. need for extra analgesic

    Time frame: 48 hour

  5. nausea

    Time frame: 48 hour

  6. vomiting

    Time frame: 48 hour

  7. thoracic and shoulder pain

    Time frame: 48 hour

  8. Urogenital distress measured by Urogenital Distress Inventory

    Time frame: One hour before cesarean and 24 hour postoperatively

  9. Oral intake

    Time frame: 48 hour

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

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Extraperitoneal Versus Transperitoneal Cesarean Section: A Prospective Randomized Comparison

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2014
Registry last updated
Jun 8, 2015

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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