The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
- Conditions
- Scars
- Interventions
- Procedure: hysterotomy at cesarean
- Registration Number
- NCT01091181
- Lead Sponsor
- Region Skane
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 122
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low incision group hysterotomy at cesarean hysterotomy at cesarean performed 2 cm below plica vesicouterina high incision group hysterotomy at cesarean hysterotomy at cesarean performed 2 cm above plica vesicouterina
- Primary Outcome Measures
Name Time Method large defect 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
Name Time Method uterina rupture/uterine dehiscence 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
scar pregnancy 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
difficulties at delivery of fetus 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
readmission to the hospital 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
miscarriage up to 8 years occurrence of miscarriage in subsequent pregnancy is assessed by the percentage of patients who have miscarriages in subsequent pregnancy
placenta previa/accreta 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
APGAR score 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.
blood loss 1 hour estimated blood loss during surgery is measured in terms of mL
postoperative infection 8 weeks postoperative infection after caesarean section is assessed by the percentage of patients who develop this complication
vaginal delivery after caesarean 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
Trial Locations
- Locations (1)
Skåne University Hospital Malmö
🇸🇪Malmö, Sweden