Study Results
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Basic Information
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UNKNOWN
NA
66 participants
INTERVENTIONAL
2020-05-31
2021-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Disimpaction with lower uterine support
Cesarean section with support of the lower uterine segment
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
Classic push method
Cesarean section with push method
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Cephalic presentation.
* The cervix is fully dilated.
* Ruptured membranes.
* Adequate uterine contractions.
* Impacted fetal head in maternal pelvis
Exclusion Criteria
* Major fetal anomalies
* Non-cephalic presentation
* Multiple pregnancy
* Preterm caesarean \< 37 weeks
* Abnormal placentation.
18 Years
40 Years
FEMALE
No
Sponsors
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Aswan University
OTHER
Assiut University
OTHER
Responsible Party
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Sherif Abdelkarim Mohammed Shazly
M.B.B.Ch, M.Sc
Principal Investigators
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Ahmed Nasr, MBBCh, MD
Role: STUDY_DIRECTOR
Assiut University
Central Contacts
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References
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Dolea C, AbouZahr C. Global burden of obstructed labour in the year 2000. World Health Organization (WHO), Geneva, Switzerland. 2003 Jul;1:17.
Neilson JP, Lavender T, Quenby S, Wray S. Obstructed labour. Br Med Bull. 2003;67:191-204. doi: 10.1093/bmb/ldg018.
Landesman R, Graber EA. Abdominovaginal delivery: modification of the cesarean section operation to facilitate delivery of the impacted head. Am J Obstet Gynecol. 1984 Mar 15;148(6):707-10. doi: 10.1016/0002-9378(84)90551-9.
Shazly SA, Elsayed AH, Badran SM, Abdel Badee AY, Ali MK. Abdominal disimpaction with lower uterine segment support as a novel technique to minimize fetal and maternal morbidities during cesarean section for obstructed labor: a case series. Am J Perinatol. 2013 Sep;30(8):695-8. doi: 10.1055/s-0032-1331031. Epub 2012 Dec 27.
Other Identifiers
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PLUS-DIH-02
Identifier Type: -
Identifier Source: org_study_id
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