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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2017-10-31

Brief Summary

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

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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.

Conditions

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Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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high incision group

hysterotomy at cesarean performed 2 cm above plica vesicouterina

Group Type ACTIVE_COMPARATOR

hysterotomy at cesarean

Intervention Type PROCEDURE

incision to open the uterus at cesarean.

low incision group

hysterotomy at cesarean performed 2 cm below plica vesicouterina

Group Type ACTIVE_COMPARATOR

hysterotomy at cesarean

Intervention Type PROCEDURE

incision to open the uterus at cesarean.

Interventions

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hysterotomy at cesarean

incision to open the uterus at cesarean.

Intervention Type PROCEDURE

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.