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

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

Detailed Description
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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.

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

Conditions
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Scars

Intervention / Treatment
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* Procedure: hysterotomy at cesarean


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high incision group<br>hysterotomy at cesarean performed 2 cm above plica vesicouterina | Procedure: hysterotomy at cesarean<br>* incision to open the uterus at cesarean.<br>|
| Active Comparator: low incision group<br>hysterotomy at cesarean performed 2 cm below plica vesicouterina | Procedure: hysterotomy at cesarean<br>* incision to open the uterus at cesarean.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 and 5 minute after delivery | 
| blood loss | estimated blood loss during surgery is measured in terms of mL | 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 | 1 hour | 
| postoperative infection | postoperative infection after caesarean section is assessed by the percentage of patients who develop this complication | 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 | 8 weeks | 
| miscarriage | occurrence of miscarriage in subsequent pregnancy is assessed by the percentage of patients who have miscarriages in subsequent pregnancy | 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 | 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 | 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 | 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 | up to 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarean