ScarsNCT01091181
The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
A study testing hysterotomy at cesarean in people with Scars, run by Region Skane at 1 site in Sweden.
Trial summary
The Effect of Cesarean Operative Technique on the Occurrence of Large Hysterotomy Scar Defects. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Scars
- What is being tested?
- hysterotomy at cesarean
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2009to 31 Oct 2017
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- gestational age ≥ 37 gestational weeks
- cervical dilatation ≥5 cm,
- no previous uterine surgery other than cone biopsy, loop electrosurgical excision procedure, dilatation and curettage, or dilatation and evacuation, undergoing emergency caesarean section.
Who cannot join
- need of immediate caesarean section, defined as delivery of the baby within 20 minutes.
Trial locations and contacts
1 site in 1 country.
About this study
The Effect of Cesarean Operative Technique on the Occurrence of Large Hysterotomy Scar Defects.
Read the detailed description
Having a Caesarean leads to a scar in the uterus, which does not always heal properly. Defective healing can lead to serious complications in the next pregnancy and delivery. Different surgical techniques can be used for a Caesarean section.
The aim is to compare two surgical techniques (different ways of opening the uterus), to investigate whether one or the other technique leads to fewer defective scars in the uterus. Both these techniques are in use at the clinic. After the operation, patients are cared for in the normal way.
Six months after the Caesarean, patients are examined using vaginal ultrasound. Vaginal ultrasound allows to see if the scar after the Caesarean has healed well, or if there are defects in it.
- Conditions
- Scars
- Being tested
- hysterotomy at cesarean
- Keywords
- Caesarean
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysterotomy at cesareanProcedure or surgery
incision to open the uterus at cesarean.
| Study group | Role | What they receive |
|---|---|---|
| high incision group | Active comparator | hysterotomy at cesarean performed 2 cm above plica vesicouterina Receives: Procedure: hysterotomy at cesarean |
| low incision group | Active comparator | hysterotomy at cesarean performed 2 cm below plica vesicouterina Receives: Procedure: hysterotomy at cesarean |
What is being measured
The primary outcome is the main question the study is designed to answer.
large defect
occurrence of large defects in uterine cesarean scar are detected by ultrasound and are assessed by the percentage of patients who have large defects in uterine cesarean scar
Measured: 6 months
Secondary outcomes (10)
APGAR score
APGAR score measured at 1 and 5 minute after delivery. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration).The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10.
Measured: 1 and 5 minute after delivery
blood loss
estimated blood loss during surgery is measured in terms of mL
Measured: 1 hour
difficulties at delivery of fetus
difficulties at delivery of fetus at caesarean are assessed by the percentage of patients when surgeons experience difficulties at delivery of fetus at caesarean
Measured: 1 hour
postoperative infection
postoperative infection after caesarean section is assessed by the percentage of patients who develop this complication
Measured: 8 weeks
readmission to the hospital
readmission to the hospital due to need of re-operation is assessed by the percentage of patients who have re-operation after caesarean
Measured: 8 weeks
miscarriage
occurrence of miscarriage in subsequent pregnancy is assessed by the percentage of patients who have miscarriages in subsequent pregnancy
Measured: up to 8 years
scar pregnancy
occurrence of scar pregnancy in subsequent pregnancy is assessed by the percentage of patients who have scar pregnancy after the index caesarean
Measured: up to 8 years
placenta previa/accreta
occurrence of placenta previa/accreta in subsequent pregnancy is assessed by the percentage of patients who have placenta previa/accreta in subsequent pregnancy
Measured: up to 8 years
uterina rupture/uterine dehiscence
occurrence of uterine rupture/uterine dehiscence in subsequent labour is assessed by the percentage of patients who have uterine rupture/uterine dehiscence in subsequent labour
Measured: up to 8 years
vaginal delivery after caesarean
success rate of vaginal delivery after caesarean is assessed by the percentage of patients who delivered vaginally after the index caesarean
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startOct 2009
- Primary completion1 Dec 2016
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- women aimed for emergency cesarean section were randomized into two groups according to surgery technique of opening the uterus: 1 Group - high level of hysterotomy incision; 2 Group - low level of hysterotomy incision. Opening and closing of abdomen performed in the same manner in both groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga Vikhareva, MD, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091181
- Sponsor's protocol ID
- 2-valentin
- Status last verified
- May 2018
- First submitted
- 19 Mar 2010
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
- ClinicalTrials.gov ID
- NCT01091181
- Acronym / sponsor ID
- 2-valentin
- Conditions
- Scars
- Keywords
- Caesarean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 23 Mar 2010 (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.
The Effect of Cesarean Operative Technique on the Occurrence of Large Hysterotomy Scar Defects.
Detailed description
Having a Caesarean leads to a scar in the uterus, which does not always heal properly. Defective healing can lead to serious complications in the next pregnancy and delivery. Different surgical techniques can be used for a Caesarean section.
The aim is to compare two surgical techniques (different ways of opening the uterus), to investigate whether one or the other technique leads to fewer defective scars in the uterus. Both these techniques are in use at the clinic. After the operation, patients are cared for in the normal way.
Six months after the Caesarean, patients are examined using vaginal ultrasound. Vaginal ultrasound allows to see if the scar after the Caesarean has healed well, or if there are defects in it.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- women aimed for emergency cesarean section were randomized into two groups according to surgery technique of opening the uterus: 1 Group - high level of hysterotomy incision; 2 Group - low level of hysterotomy incision. Opening and closing of abdomen performed in the same manner in both groups
| Arm | Type | Receives |
|---|---|---|
| high incision group | Active comparator | Procedure: hysterotomy at cesareanhysterotomy at cesarean performed 2 cm above plica vesicouterina |
| low incision group | Active comparator | Procedure: hysterotomy at cesareanhysterotomy at cesarean performed 2 cm below plica vesicouterina |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years old
- gestational age ≥ 37 gestational weeks
- cervical dilatation ≥5 cm,
- no previous uterine surgery other than cone biopsy, loop electrosurgical excision procedure, dilatation and curettage, or dilatation and evacuation, undergoing emergency caesarean section.
Key exclusion criteria (1 listed)
- need of immediate caesarean section, defined as delivery of the baby within 20 minutes.
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 |
|---|---|---|
| hysterotomy at cesareanincision to open the uterus at cesarean. | Procedure or surgery | high incision group, low incision group |
Primary outcome
large defect
Time frame: 6 months
occurrence of large defects in uterine cesarean scar are detected by ultrasound and are assessed by the percentage of patients who have large defects in uterine cesarean scar
10 secondary outcomes
APGAR score
Time frame: 1 and 5 minute after delivery
blood loss
Time frame: 1 hour
difficulties at delivery of fetus
Time frame: 1 hour
postoperative infection
Time frame: 8 weeks
readmission to the hospital
Time frame: 8 weeks
miscarriage
Time frame: up to 8 years
scar pregnancy
Time frame: up to 8 years
placenta previa/accreta
Time frame: up to 8 years
uterina rupture/uterine dehiscence
Time frame: up to 8 years
vaginal delivery after caesarean
Time frame: up to 8 years
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 May 2018.
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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.
Olga Vikhareva, MD, PhD principal investigator
Skane University 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 hysterotomy at cesarean in people with Scars, run by Region Skane at 1 site in Sweden.
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 1 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 May 2018. 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 Sweden. 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?
large defect (time frame: 6 months). 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 May 2018.