Push With Lower Uterine Segment Support

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dystocia

Intervention / Treatment
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* Procedure: Cesarean section


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disimpaction with lower uterine support<br>Cesarean section with support of the lower uterine segment | Procedure: Cesarean section<br>* Abdominal disimpaction with lower uterine segment support: the edge of the lower uterine segment is grasped by 3-4 modified Allies forceps (with broader jaws) applied along the lower edge of the incision until it is completely supported. These forceps are handled by the assistant, and gentle traction is applied upward, perpendicular to the uterine surface and away from the fetal head without excessive force. Accordingly, the hand of the surgeon could be inserted into the uterine cavity, and adequate space for manipulations is available without applying pressure on the lower segment. The fetal head is eventually grasped and delivered. Classic push method: delivering the head with assistance by pushing the fetal head vaginally<br>|
| Active Comparator: Classic push method<br>Cesarean section with push method | Procedure: Cesarean section<br>* Abdominal disimpaction with lower uterine segment support: the edge of the lower uterine segment is grasped by 3-4 modified Allies forceps (with broader jaws) applied along the lower edge of the incision until it is completely supported. These forceps are handled by the assistant, and gentle traction is applied upward, perpendicular to the uterine surface and away from the fetal head without excessive force. Accordingly, the hand of the surgeon could be inserted into the uterine cavity, and adequate space for manipulations is available without applying pressure on the lower segment. The fetal head is eventually grasped and delivered. Classic push method: delivering the head with assistance by pushing the fetal head vaginally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extension of uterine incision | The incidence of extension of uterine incision | During delivery of the fetus | 
| Length of extension of uterine incision | If extension of uterine incision happens, the length of extension will be measured | During delivery of the fetus | 
| Injury of the vagina | Extension of uterine incision into the vagina | During delivery of the fetus | 
| Injury of the bladder | Extension of uterine incision into the bladder | During delivery of the fetus | 
| Injury of the ureter | Extension of uterine incision into the ureter | During delivery of the fetus | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructed labor, C section. push method, reverse breech