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The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar

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ClinicalTrials.gov Identifier: NCT01091181
Recruitment Status : Completed
First Posted : March 23, 2010
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Region Skane

Brief Summary:
The Effect of Cesarean Operative Technique on the Occurrence of Large Hysterotomy Scar Defects.

Condition or disease Intervention/treatment Phase
Scars Procedure: hysterotomy at cesarean Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: the surgeon who performed the operation knew what technique to use. Participant were not informed in what group they were. Six months postpartum patients came to ultrasound department and underwent ultrasound examination of uterus and uterine cesarean scar. Sonographer was blinded to the surgery technique.
Primary Purpose: Other
Official Title: The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
Actual Study Start Date : October 2009
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Active Comparator: high incision group
hysterotomy at cesarean performed 2 cm above plica vesicouterina
Procedure: hysterotomy at cesarean
incision to open the uterus at cesarean.

Active Comparator: low incision group
hysterotomy at cesarean performed 2 cm below plica vesicouterina
Procedure: hysterotomy at cesarean
incision to open the uterus at cesarean.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. APGAR score [ Time Frame: 1 and 5 minute after delivery ]
    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.

  2. blood loss [ Time Frame: 1 hour ]
    estimated blood loss during surgery is measured in terms of mL

  3. difficulties at delivery of fetus [ Time Frame: 1 hour ]
    difficulties at delivery of fetus at caesarean are assessed by the percentage of patients when surgeons experience difficulties at delivery of fetus at caesarean

  4. postoperative infection [ Time Frame: 8 weeks ]
    postoperative infection after caesarean section is assessed by the percentage of patients who develop this complication

  5. readmission to the hospital [ Time Frame: 8 weeks ]
    readmission to the hospital due to need of re-operation is assessed by the percentage of patients who have re-operation after caesarean

  6. miscarriage [ Time Frame: up to 8 years ]
    occurrence of miscarriage in subsequent pregnancy is assessed by the percentage of patients who have miscarriages in subsequent pregnancy

  7. scar pregnancy [ Time Frame: up to 8 years ]
    occurrence of scar pregnancy in subsequent pregnancy is assessed by the percentage of patients who have scar pregnancy after the index caesarean

  8. placenta previa/accreta [ Time Frame: up to 8 years ]
    occurrence of placenta previa/accreta in subsequent pregnancy is assessed by the percentage of patients who have placenta previa/accreta in subsequent pregnancy

  9. uterina rupture/uterine dehiscence [ Time Frame: up to 8 years ]
    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

  10. vaginal delivery after caesarean [ Time Frame: up to 8 years ]
    success rate of vaginal delivery after caesarean is assessed by the percentage of patients who delivered vaginally after the index caesarean



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

inclusion criteria:

  • ≥ 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.

exclusion criteria:

• need of immediate caesarean section, defined as delivery of the baby within 20 minutes.


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): NCT01091181


Locations
Sweden
Skåne University Hospital Malmö
Malmö, Sweden, Se 20502
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Olga Vikhareva, MD, PhD Skane University Hospital

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01091181     History of Changes
Obsolete Identifiers: NCT03498339
Other Study ID Numbers: 2-valentin
First Posted: March 23, 2010    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Keywords provided by Region Skane:
Caesarean