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Completed

NCT Number: NCT01892215

Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad,

Obstetrical blood loss is an important reason of maternal morbidity and mortality. Because of the increase in the rate of cesarean section, any procedure that could help reduce blood loss during cesarean section should be investigated. The purpose of this study was to compare 2 methods of blunt expansion of the uterine incision at the time of cesarean delivery: transversal vs. cephalad-caudad.

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Key information

Conditions

Blunt Expansion of the Uterine Incision

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas Maternity Hospital

Panama City, Panama

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Singleton pregnancies
  • Gestational age: 34 weeks or more
  • Delivery by cesarean section
  • Presurgical hemoglobin > 10.5 g/dL

Exclusion criteria

  • Two or more previous cesarean sections
  • History of uterine rupture in a previous pregnancy
  • History of myomectomy
  • History of abdominal trauma with an uterine lesion
  • Blood dyscrasia
  • Multiple pregnancy
  • Placenta previa
  • Abruptio placenta
  • Stillbirth
  • Sharp uterine expansion

Treatment and study plan

Cephalad-caudad expansion

Procedure

Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.

Transversal expansion

Procedure

Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.

Primary outcomes

  1. Blood loss (hemoglobin level)

    Time frame: 72 hours

    Difference in hemoglobin level between 24 hours pre-surgery and the hemoglobin level before leaving the hospital.

Secondary outcomes

  1. Surgical complications

    Time frame: 72 hours

    Number of cases of surgical complications (hematomas, unintended extension of the uterine incision, need for transfusion) between the two techniques.

  2. Unintented extension of uterine incision

    Time frame: 72 hours

    Number of cases of unintended extension of the uterine incision during surgery between the two techniques.

  3. Hematoma formation

    Time frame: 72 hours

    Number of cases of hematoma formation during or after between the two techniques.

  4. Need for transfusion

    Time frame: 72 hours

    Number of cases that required a blood transfusion between the two techniques.

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad. A Randomized, Controlled Trial.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 4, 2013
Registry last updated
Jun 22, 2017

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.