Clinical Trial: Push With Lower Uterine Segment Support

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Delivery of Impacted Fetal Head During Cesarean Section for Obstructed Labor: Push Method Versus Abdominal Disimpaction With Lower Uterine Segment Support

Brief Summary: The study aims to compare maternal and early neonatal outcomes of abdominal disimpaction with lower uterine segment support in comparison to the classic "push" method for delivery of impacted fetal head during Cesarean section for obstructed labor.

Detailed Summary:

Obstructed labor refers to failure of labor progress in spite of good uterine contractions and is attributed to mismatch between the size of the presenting part of the fetus and the mother's pelvis. Approximately 8% of maternal deaths worldwide are attributed to obstructed labor and subsequent puerperal infection, uterine rupture, and postpartum hemorrhage.

In these situations, Cesarean section could minimize maternal and neonatal morbidity. However, Cesarean section is challenging when the head is deeply impacted and is associated with high risk of maternal injuries and perinatal injuries. The most common complication is extension of uterine incision which could involve the vagina, bladder, ureters and broad ligament. Neonates are also at risk of skull fractures, cephalhematoma, and subgaleal hematoma mainly due to manipulations. Currently, the most popular approaches for fetal head delivery are the push and pull methods. Although push method seems to be more convenient and does not necessitate extensive experience, it is more significantly associated with extension than the pull method. Although pull method seems to be more safe, it is more difficult to perform and usually warrants an aggressive uterine incision to deliver the fetus. In 2013, investigators published a case series on abdominal disimpaction with lower uterine segment support which basically allows obstetricians to deliver the fetal head through a transverse uterine incision with minimal risk of extensions and neonatal complications. In this study, investigators aim to validate this approach in comparison to the classic push method.


Sponsor: Assiut University

Current Primary Outcome:

  • Extension of uterine incision [ Time Frame: During delivery of the fetus ]
    The incidence of extension of uterine incision
  • Length of extension of uterine incision [ Time Frame: During delivery of the fetus ]
    If extension of uterine incision happens, the length of extension will be measured
  • Injury of the vagina [ Time Frame: During delivery of the fetus ]
    Extension of uterine incision into the vagina
  • Injury of the bladder [ Time Frame: During delivery of the fetus ]
    Extension of uterine incision into the bladder
  • Injury of the ureter [ Time Frame: During delivery of the fetus ]
    Extension of uterine incision into the ureter


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cesarean section operative time [ Time Frame: Time from incision to closure of the skin (within 24 hours of recruitment) ]
    Duration of Cesarean section operation
  • Intra-operative blood loss [ Time Frame: During Cesarean section only ]
    Amount of blood loss as estimated by suction device from incision to closure of the skin
  • The incidence of postpartum hemorrhage [ Time Frame: During the first 24 hours post-operative ]
    Loss of more than 500 ml during the first 24 hours after surgery and the management that will be done
  • Incidence of blood transfusion [ Time Frame: During surgery and within the first 24 hours postoperative ]
    The incidence of blood transfusion due to significant blood loss (based on blood loss and clinical judgement "hypotension, tachycardia, pallor")
  • Fetal traumatic birth injuries [ Time Frame: During Cesarean section (fetal delivery) ]
    Skull fractures, limb fractures, brachial plexus injury, cephalhematoma, and subgaleal hematoma
  • APGAR score [ Time Frame: At 1 and 5 minutes after delivery of the newborn ]
  • Need for neonatal admission to neonatal intensive care unit [ Time Frame: Within 24 hours of delivery of the newborn ]
  • Postoperative infections [ Time Frame: 1 week of postpartum ]
    Puerperal sepsis and Cesarean section wound infection


Original Secondary Outcome: Same as current

Information By: Assiut University

Dates:
Date Received: October 13, 2016
Date Started: December 2016
Date Completion: March 2018
Last Updated: October 13, 2016
Last Verified: October 2016