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

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ClinicalTrials.gov Identifier: NCT01892215
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blunt Expansion of the Uterine Incision Procedure: Cephalad-caudad expansion Procedure: Transversal expansion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 839 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad. A Randomized, Controlled Trial.
Study Start Date : October 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cephalad-caudad
Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.
Procedure: Cephalad-caudad expansion
Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.

Experimental: Transversal expansion
Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.
Procedure: Transversal expansion
Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892215


Locations
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Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
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Principal Investigator: Osvaldo Reyes, MD Saint Thomas Maternity Hospital
Principal Investigator: Alberto Morales, MD Saint Thomas Maternity Hospital

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Responsible Party: Osvaldo A. Reyes T., Coordinator of Research, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01892215     History of Changes
Other Study ID Numbers: MHST2012-08
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Uterine incision.
Blunt transversal expansion.
Blunt cephalad-caudad expansion.
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries