Blunt Expansion of the Uterine IncisionNCT01892215
Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad,
A study testing Cephalad-caudad expansion and Transversal expansion in people with Blunt Expansion of the Uterine Incision, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Blunt Expansion of the Uterine Incision
- What is being tested?
- Cephalad-caudad expansion and Transversal expansion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 839 participants
- Where
- 1 sitePanama
- Study dates
- Oct 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Singleton pregnancies
- Gestational age: 34 weeks or more
- Delivery by cesarean section
- Presurgical hemoglobin > 10.5 g/dL
Who cannot join
- 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
Show all 10Show fewer
- Placenta previa
- Abruptio placenta
- Stillbirth
- Sharp uterine expansion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad. A Randomized, Controlled Trial.
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.
- Conditions
- Blunt Expansion of the Uterine Incision
- Being tested
- Cephalad-caudad expansion, Transversal expansion
- Keywords
- Uterine incision., Blunt transversal expansion., Blunt cephalad-caudad expansion.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cephalad-caudad expansionProcedure or surgery
Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.
Transversal expansionProcedure or surgery
Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.
| Study group | Role | What they receive |
|---|---|---|
| Cephalad-caudad | Experimental | Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction. Receives: Procedure: Cephalad-caudad expansion |
| Transversal expansion | Experimental | Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction. Receives: Procedure: Transversal expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss (hemoglobin level)
Difference in hemoglobin level between 24 hours pre-surgery and the hemoglobin level before leaving the hospital.
Measured: 72 hours
Secondary outcomes (4)
Surgical complications
Number of cases of surgical complications (hematomas, unintended extension of the uterine incision, need for transfusion) between the two techniques.
Measured: 72 hours
Unintented extension of uterine incision
Number of cases of unintended extension of the uterine incision during surgery between the two techniques.
Measured: 72 hours
Hematoma formation
Number of cases of hematoma formation during or after between the two techniques.
Measured: 72 hours
Need for transfusion
Number of cases that required a blood transfusion between the two techniques.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunt Expansion of the Uterine IncisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo Reyes, MD, Principal investigator, Saint Thomas Maternity HospitalAlberto Morales, MD, Principal investigator, Saint Thomas Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892215
- Sponsor's protocol ID
- MHST2012-08
- Status last verified
- Jun 2017
- First submitted
- 30 Jun 2013
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad. A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01892215
- Acronym / sponsor ID
- MHST2012-08
- Conditions
- Blunt Expansion of the Uterine Incision
- Keywords
- Uterine incision., Blunt transversal expansion., Blunt cephalad-caudad expansion.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 839 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cephalad-caudad | Experimental | Procedure: Cephalad-caudad expansionBlunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction. |
| Transversal expansion | Experimental | Procedure: Transversal expansionBlunt expansion of the uterine incision by the physician separating the fingers in a transversal direction. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton pregnancies
- Gestational age: 34 weeks or more
- Delivery by cesarean section
- Presurgical hemoglobin > 10.5 g/dL
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cephalad-caudad expansionBlunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction. | Procedure or surgery | Cephalad-caudad |
| Transversal expansionBlunt expansion of the uterine incision by the physician separating the fingers in a transversal direction. | Procedure or surgery | Transversal expansion |
Primary outcome
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.
4 secondary outcomes
Surgical complications
Time frame: 72 hours
Unintented extension of uterine incision
Time frame: 72 hours
Hematoma formation
Time frame: 72 hours
Need for transfusion
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osvaldo Reyes, MD principal investigator
Saint Thomas Maternity Hospital
Alberto Morales, MD principal investigator
Saint Thomas Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cephalad-caudad expansion and Transversal expansion in people with Blunt Expansion of the Uterine Incision, run by Saint Thomas Hospital, Panama at 1 site in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (hemoglobin level) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.