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Push With Lower Uterine Segment Support

Not Applicable
Conditions
Dystocia
Interventions
Procedure: Cesarean section
Registration Number
NCT02934516
Lead Sponsor
Assiut University
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 Description

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
66
Inclusion Criteria
  • Singleton term pregnancy, 37 to 42 weeks of gestation.
  • Cephalic presentation.
  • The cervix is fully dilated.
  • Ruptured membranes.
  • Adequate uterine contractions.
  • Impacted fetal head in maternal pelvis
Exclusion Criteria
  • Intrauterine fetal death
  • Major fetal anomalies
  • Non-cephalic presentation
  • Multiple pregnancy
  • Preterm caesarean < 37 weeks
  • Abnormal placentation.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Disimpaction with lower uterine supportCesarean sectionCesarean section with support of the lower uterine segment
Classic push methodCesarean sectionCesarean section with push method
Primary Outcome Measures
NameTimeMethod
Extension of uterine incisionDuring delivery of the fetus

The incidence of extension of uterine incision

Length of extension of uterine incisionDuring delivery of the fetus

If extension of uterine incision happens, the length of extension will be measured

Injury of the vaginaDuring delivery of the fetus

Extension of uterine incision into the vagina

Injury of the bladderDuring delivery of the fetus

Extension of uterine incision into the bladder

Injury of the ureterDuring delivery of the fetus

Extension of uterine incision into the ureter

Secondary Outcome Measures
NameTimeMethod
APGAR scoreAt 1 and 5 minutes after delivery of the newborn
Cesarean section operative timeTime from incision to closure of the skin (within 24 hours of recruitment)

Duration of Cesarean section operation

Intra-operative blood lossDuring Cesarean section only

Amount of blood loss as estimated by suction device from incision to closure of the skin

The incidence of postpartum hemorrhageDuring 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 transfusionDuring 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 injuriesDuring Cesarean section (fetal delivery)

Skull fractures, limb fractures, brachial plexus injury, cephalhematoma, and subgaleal hematoma

Need for neonatal admission to neonatal intensive care unitWithin 24 hours of delivery of the newborn
Postoperative infections1 week of postpartum

Puerperal sepsis and Cesarean section wound infection

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