An interventional study of Cesarean section in Dystocia, sponsored by Assiut University. Status unknown. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's planned enrollment of 66 is below the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Cesarean section with support of the lower uterine segment
Procedure: Cesarean section
Cesarean section with push method
Procedure: Cesarean section
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
Extension of uterine incision
The incidence of extension of uterine incision
Time frame: During delivery of the fetus
Length of extension of uterine incision
If extension of uterine incision happens, the length of extension will be measured
Time frame: During delivery of the fetus
Injury of the vagina
Extension of uterine incision into the vagina
Time frame: During delivery of the fetus
Injury of the bladder
Extension of uterine incision into the bladder
Time frame: During delivery of the fetus
Injury of the ureter
Extension of uterine incision into the ureter
Time frame: During delivery of the fetus
Cesarean section operative time
Duration of Cesarean section operation
Time frame: 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
Time frame: 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
Time frame: 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")
Time frame: During surgery and within the first 24 hours postoperative
Fetal traumatic birth injuries
Skull fractures, limb fractures, brachial plexus injury, cephalhematoma, and subgaleal hematoma
Time frame: During Cesarean section (fetal delivery)
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
Puerperal sepsis and Cesarean section wound infection
Time frame: 1 week of postpartum
No study locations are listed for this record.
Plan to share: No
Start is estimated for May 2020; primary completion for Apr 2021, 11 months later.
Of 18 interventional studies with no phase under Dystocia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 40. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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