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Hand Forceps vs. Conventional One-hand Technique for Fetal Head Extraction During Cesarean Section (Hand forceps)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159857
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Xuezhi (Daniel) Jiang, MD, The Reading Hospital and Medical Center

Brief Summary:

The aim of the study is to assess the efficacy and safety of an innovative two-hand (hand forceps) fetal head extraction technique during the transverse cesarean sections (LTCS) by comparing with the conventional one-hand technique used worldwide for centuries.

The primary research question of the study is whether two-hand fetal head extraction technique results in quicker head delivery. The secondary research question is whether two-hand technique would cause increased incidence of extension of uterine incision as well as other adverse events while compared to conventional one-hand technique.

Our hypothesis is that two-hand technique would speed up fetal head delivery without increasing the risk of extension of uterine incision as well as other adverse events, in the meantime, maternal discomfort will be significantly reduced since fundal pressure will not be required during the fetal head delivery.


Condition or disease Intervention/treatment Phase
Pregnancy Related Delivery Complication Cesarean Delivery Affecting Fetus Procedure: Fetal head extraction technique during the cesarean section Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arm 1: Fetal head is extracted by conventional one-hand (in hysterotomy) technique during the C-section Arm 2: Fetal head is extracted by an innovative two-hand (in hysterotomy) technique during the C-section
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Efficacy and Safety Comparison of an Innovative Two-hand vs. Conventional One-hand Technique for Fetal Head Manual Extraction During a Low Transverse Cesarean Section: A Randomized Controlled Study
Actual Study Start Date : January 28, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: One-hand
During LTCS, the fetal head traditionally is delivered by one-hand manual extraction (a surgeon inserts one hand into the uterus via the hysterotomy and lifts the fetal head out of maternal pelvis, subsequently significant abdominal pressure is required to squeeze the fetal head out of hysterotomy) along with application of significant abdominal/fundal pressure.
Procedure: Fetal head extraction technique during the cesarean section
see above for the description about one-hand and two-hand fetal head extraction technique

Experimental: Two-hand
An innovative approach to manual head extraction, with surgeon's both hands formed as a pair of forceps, has been used by the PI of this study for years during the LTCS for head extraction in the difficult situations described above without complication, often time it was used after one hand approach failed to deliver the infant, vacuum/forceps and abdominal pressure usually was not needed in these cases.
Procedure: Fetal head extraction technique during the cesarean section
see above for the description about one-hand and two-hand fetal head extraction technique




Primary Outcome Measures :
  1. Time needed for fetal head delivery [ Time Frame: 1 year ]
    Time from entry of uterus to delivery of fetal head (U-D interval)


Secondary Outcome Measures :
  1. Extension of hysterotomy [ Time Frame: 1 year ]
    incidence of extension of uterine incision as well as other adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age (GA) 37 weeks or above with cephalic presentation
  • Planned low transverse uterine incision
  • Cervical dilation <= 6cm
  • Station < 0.

Exclusion Criteria:

  • Preterm GA <37 weeks
  • Planned classical C-section
  • Unable or unwilling to afford abdominal pressure during the delivery of fetal head
  • Advanced cervical dilation >6cm
  • Station >=0

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159857


Contacts
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Contact: Xuezhi (Daniel) Jiang, MD 4846288981 daniel.jiang@towerhealth.org

Locations
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United States, Pennsylvania
Reading Hospital Labor & Delivery Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Jonathan Rodger, MD       jonathan.rodger@towerhealth.org   
Sponsors and Collaborators
The Reading Hospital and Medical Center
Investigators
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Principal Investigator: Xuezhi (Daniel) Jiang, MD Reading Hospital of Tower Health
Publications of Results:
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Responsible Party: Xuezhi (Daniel) Jiang, MD, Research and Clerkship Director of OBGYN, The Reading Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT04159857    
Other Study ID Numbers: IRB 028-18
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xuezhi (Daniel) Jiang, MD, The Reading Hospital and Medical Center:
hand forceps, cesarean section, one-hand technique, two-hand technique, fetal head extraction