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

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

Study Overview

• Status: Completed
• Conditions: Scars
• Intervention / Treatment: Procedure: hysterotomy at cesarean

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, Se 20502
    • Skåne University Hospital Malmö

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: high incision group; hysterotomy at cesarean performed 2 cm above plica vesicouterina	Procedure: hysterotomy at cesarean; incision to open the uterus at cesarean.
ACTIVE_COMPARATOR: low incision group; hysterotomy at cesarean performed 2 cm below plica vesicouterina	Procedure: hysterotomy at cesarean; incision to open the uterus at cesarean.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Olga Vikhareva, MD, PhD, Skane University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2009
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): October 31, 2017

Study Registration Dates

• First Submitted: March 19, 2010
• First Submitted That Met QC Criteria: March 22, 2010
• First Posted (ESTIMATE): March 23, 2010

Study Record Updates

• Last Update Posted (ACTUAL): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Caesarean
• Other Study ID Numbers: 2-valentin