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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystocia focused on measuring Obstructed labor, C section. push method, reverse breech

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    October 13, 2016
    Last Updated
    February 26, 2020
    Sponsor
    Assiut University
    Collaborators
    Aswan University
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    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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