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

Region Skane122 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

122

Conditions

Scars

Interventions

hysterotomy at cesareanPROCEDURE

incision to open the uterus at cesarean.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Skåne University Hospital Malmö

Malmo, Sweden

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 1 and 5 minute after delivery

blood loss

estimated blood loss during surgery is measured in terms of mL

Time frame: 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

Time frame: 1 hour

postoperative infection

postoperative infection after caesarean section is assessed by the percentage of patients who develop this complication

Time frame: 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

Time frame: 8 weeks

miscarriage

occurrence of miscarriage in subsequent pregnancy is assessed by the percentage of patients who have miscarriages in subsequent pregnancy

Data from ClinicalTrials.gov

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