Push With Lower Uterine Segment Support (PLUS)
Primary Purpose
Dystocia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cesarean section
Sponsored by
About this trial
This is an interventional treatment trial for Dystocia focused on measuring Obstructed labor, C section. push method, reverse breech
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Disimpaction with lower uterine support
Classic push method
Arm Description
Cesarean section with support of the lower uterine segment
Cesarean section with push method
Outcomes
Primary Outcome Measures
Extension of uterine incision
The incidence of extension of uterine incision
Length of extension of uterine incision
If extension of uterine incision happens, the length of extension will be measured
Injury of the vagina
Extension of uterine incision into the vagina
Injury of the bladder
Extension of uterine incision into the bladder
Injury of the ureter
Extension of uterine incision into the ureter
Secondary Outcome Measures
Cesarean section operative time
Duration of Cesarean section operation
Intra-operative blood loss
Amount of blood loss as estimated by suction device from incision to closure of the skin
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
Incidence of blood transfusion
The incidence of blood transfusion due to significant blood loss (based on blood loss and clinical judgement "hypotension, tachycardia, pallor")
Fetal traumatic birth injuries
Skull fractures, limb fractures, brachial plexus injury, cephalhematoma, and subgaleal hematoma
APGAR score
Need for neonatal admission to neonatal intensive care unit
Postoperative infections
Puerperal sepsis and Cesarean section wound infection
Full Information
NCT ID
NCT02934516
First Posted
October 13, 2016
Last Updated
February 26, 2020
Sponsor
Assiut University
Collaborators
Aswan University
1. Study Identification
Unique Protocol Identification Number
NCT02934516
Brief Title
Push With Lower Uterine Segment Support
Acronym
PLUS
Official Title
Delivery of Impacted Fetal Head During Cesarean Section for Obstructed Labor: Push Method Versus Abdominal Disimpaction With Lower Uterine Segment Support
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
Collaborators
Aswan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystocia
Keywords
Obstructed labor, C section. push method, reverse breech
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Disimpaction with lower uterine support
Arm Type
Experimental
Arm Description
Cesarean section with support of the lower uterine segment
Arm Title
Classic push method
Arm Type
Active Comparator
Arm Description
Cesarean section with push method
Intervention Type
Procedure
Intervention Name(s)
Cesarean section
Intervention Description
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
Primary Outcome Measure Information:
Title
Extension of uterine incision
Description
The incidence of extension of uterine incision
Time Frame
During delivery of the fetus
Title
Length of extension of uterine incision
Description
If extension of uterine incision happens, the length of extension will be measured
Time Frame
During delivery of the fetus
Title
Injury of the vagina
Description
Extension of uterine incision into the vagina
Time Frame
During delivery of the fetus
Title
Injury of the bladder
Description
Extension of uterine incision into the bladder
Time Frame
During delivery of the fetus
Title
Injury of the ureter
Description
Extension of uterine incision into the ureter
Time Frame
During delivery of the fetus
Secondary Outcome Measure Information:
Title
Cesarean section operative time
Description
Duration of Cesarean section operation
Time Frame
Time from incision to closure of the skin (within 24 hours of recruitment)
Title
Intra-operative blood loss
Description
Amount of blood loss as estimated by suction device from incision to closure of the skin
Time Frame
During Cesarean section only
Title
The incidence of postpartum hemorrhage
Description
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
Title
Incidence of blood transfusion
Description
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
Title
Fetal traumatic birth injuries
Description
Skull fractures, limb fractures, brachial plexus injury, cephalhematoma, and subgaleal hematoma
Time Frame
During Cesarean section (fetal delivery)
Title
APGAR score
Time Frame
At 1 and 5 minutes after delivery of the newborn
Title
Need for neonatal admission to neonatal intensive care unit
Time Frame
Within 24 hours of delivery of the newborn
Title
Postoperative infections
Description
Puerperal sepsis and Cesarean section wound infection
Time Frame
1 week of postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherif A. Shazly, MBBCh, MSc
Phone
+15075131392
Email
shazly.sherif2020@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Shehata, MBBCh, MD
Email
Love_like902@Yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Nasr, MBBCh, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Dolea C, AbouZahr C. Global burden of obstructed labour in the year 2000. World Health Organization (WHO), Geneva, Switzerland. 2003 Jul;1:17.
Results Reference
background
PubMed Identifier
14711764
Citation
Neilson JP, Lavender T, Quenby S, Wray S. Obstructed labour. Br Med Bull. 2003;67:191-204. doi: 10.1093/bmb/ldg018.
Results Reference
background
PubMed Identifier
6702937
Citation
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.
Results Reference
background
PubMed Identifier
23271386
Citation
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.
Results Reference
background
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Push With Lower Uterine Segment Support
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