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

Cesarean Section; Dehiscence Clinical Trial

Official title:

Hysterotomy Level at Caesarean and Occurrence of Large Scar Defects: a Randomized Single-blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498339
• Other study ID #: 2008/679
• Status: Completed
• Phase: N/A
• First received: March 13, 2018
• Last updated: April 6, 2018
• Start date: March 30, 2010
• Est. completion date: October 31, 2017

Study information

• Verified date: April 2018
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section; Dehiscence

Intervention

Procedure:
• hysterotomy at cesarean
incision to open the uterus at cesarean.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	5 minutes after delivery
Secondary	blood loss	estimated blood loss during surgery is measured in terms of mL	1 hour
Secondary	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	8 weeks
Secondary	postoperative infection	postoperative infection after caesarean section is assessed by the percentage of patients who develop this complication	8 weeks
Secondary	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
Secondary	miscarriage	occurrence of miscarriage in subsequent pregnancy is assessed by the percentage of patients who have miscarriages in subsequent pregnancy	up to 8 years
Secondary	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
Secondary	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
Secondary	uterine 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
Secondary	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