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CompletedNCT01892215Updated Jun 22, 2017

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

An interventional study of Cephalad-caudad expansion and Transversal expansion in Blunt Expansion of the Uterine Incision, sponsored by Saint Thomas Hospital, Panama. Completed at 1 site in Panama. Open to female participants. Per ClinicalTrials.gov, last updated 2017-06-22.

Sponsored by Saint Thomas Hospital, Panama · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
839
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • Blunt Expansion of the Uterine Incision

Keywords

  • Uterine incision.
  • Blunt transversal expansion.
  • Blunt cephalad-caudad expansion.
03

In context

Lead sponsor

Saint Thomas Hospital, Panama is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
839 participants (actual)

Study arms

  • Experimental
    Cephalad-caudad

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

    Procedure: Cephalad-caudad expansion

  • Experimental
    Transversal expansion

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

    Procedure: Transversal expansion

Interventions

  • ProcedureCephalad-caudad expansion

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

  • ProcedureTransversal expansion

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

06

What researchers measure

Primary outcomes

  1. Blood loss (hemoglobin level)

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

    Time frame: 72 hours

Secondary outcomes

  1. Surgical complications

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

    Time frame: 72 hours

  2. Unintented extension of uterine incision

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

    Time frame: 72 hours

  3. Hematoma formation

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

    Time frame: 72 hours

  4. Need for transfusion

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

    Time frame: 72 hours

07

Study locations

1 site
  • Saint Thomas Maternity Hospital
    Panama City, Panama
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2012, a primary completion of May 2013 and a completion of Jun 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2013
First posted
Jul 4, 2013
Start
Oct 2012
Primary completionActual
May 2013
CompletionActual
Jun 2013
Last update
Jun 22, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01892215
Lead sponsor
Saint Thomas Hospital, Panama
Responsible party
Osvaldo A. Reyes T. (Coordinator of Research, Saint Thomas Hospital, Panama) — Principal investigator
First posted
Jul 4, 2013
Start date
Oct 2012
Primary completion
May 2013
Completion
Jun 2013
Last update
Jun 22, 2017

Study contacts

Osvaldo Reyes, MD
principal investigator · Saint Thomas Maternity Hospital
Alberto Morales, MD
principal investigator · Saint Thomas Maternity Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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