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Completed

NCT Number: NCT01091181

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.

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Key information

Conditions

Scars Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Skåne University Hospital Malmö

Malmö, Se 20502, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hysterotomy at cesarean

Procedure

incision to open the uterus at cesarean.

Primary outcomes

  1. large defect

    Time frame: 6 months

    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

Secondary outcomes

  1. APGAR score

    Time frame: 1 and 5 minute after delivery

    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.

  2. blood loss

    Time frame: 1 hour

    estimated blood loss during surgery is measured in terms of mL

  3. difficulties at delivery of fetus

    Time frame: 1 hour

    difficulties at delivery of fetus at caesarean are assessed by the percentage of patients when surgeons experience difficulties at delivery of fetus at caesarean

  4. postoperative infection

    Time frame: 8 weeks

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

  5. readmission to the hospital

    Time frame: 8 weeks

    readmission to the hospital due to need of re-operation is assessed by the percentage of patients who have re-operation after caesarean

  6. miscarriage

    Time frame: up to 8 years

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

  7. scar pregnancy

    Time frame: up to 8 years

    occurrence of scar pregnancy in subsequent pregnancy is assessed by the percentage of patients who have scar pregnancy after the index caesarean

  8. placenta previa/accreta

    Time frame: up to 8 years

    occurrence of placenta previa/accreta in subsequent pregnancy is assessed by the percentage of patients who have placenta previa/accreta in subsequent pregnancy

  9. uterina rupture/uterine dehiscence

    Time frame: up to 8 years

    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

  10. vaginal delivery after caesarean

    Time frame: up to 8 years

    success rate of vaginal delivery after caesarean is assessed by the percentage of patients who delivered vaginally after the index caesarean

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2017
First posted
Mar 23, 2010
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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