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

Region Skane

Status: Completed

Conditions: Scars

Treatments: Procedure: hysterotomy at cesarean

Study type: Interventional

Funder types: Other

Identifiers

NCT01091181

2-valentin

Details and patient eligibility

About

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

Full 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.

Enrollment: 122 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups

high incision group

Active Comparator group

Description:

hysterotomy at cesarean performed 2 cm above plica vesicouterina

Treatment:

Procedure: hysterotomy at cesarean

low incision group

Active Comparator group

Description:

hysterotomy at cesarean performed 2 cm below plica vesicouterina

Treatment:

Procedure: hysterotomy at cesarean