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Efficacy and Safety of Hyaluronidase for Preventing Perineal Trauma during Vaginal Delivery in Nulliparous Women: A Randomized, Double-blind, Placebo-controlled Clinical Trial

Status Approved

  • First Submitted Date

    2018/03/28

  • Registered Date

    2018/05/09

  • Last Updated Date

    2018/05/04

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0002855
    Unique Protocol ID SCHUH 2015-10-014
    Public/Brief Title Clinical Trial to evalute the Efficacy and Safety of Hyaluronidase for Vaginal Delivery in Nulliparous Women
    Scientific Title Efficacy and Safety of Hyaluronidase for Preventing Perineal Trauma during Vaginal Delivery in Nulliparous Women: A Randomized, Double-blind, Placebo-controlled Clinical Trial
    Acronym HIRAX
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry No
    Healthcare Benefit Approval Status

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number SCHUH 2015-10-014
    Approval Date 2015-10-27
    Institutional Review Board Name Soonchunhyang University Seoul Hospital Clinical Research Review Committee
    Institutional Review Board Address 59, Daesagwan-ro, Yongsan-gu, Seoul
    Institutional Review Board Telephone 02-709-9750
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Gyuyeon Choi
    Title Professor
    Telephone +82-2-709-9324
    Affiliation Soon Chun Hyang University Hospital Seoul
    Address 59, Daesagwan-ro (657 Hannam-dong), Yongsan-gu, Seoul, Korea
    Contact Person for Public Queries
    Name Gyuyeon Choi
    Title Professor
    Telephone +82-2-709-9324
    Affiliation Soon Chun Hyang University Hospital Seoul
    Address 59, Daesagwan-ro (657 Hannam-dong), Yongsan-gu, Seoul, Korea
    Contact Person for Updating Information
    Name Gyuyeon Choi
    Title Professor
    Telephone +82-2-709-9324
    Affiliation Soon Chun Hyang University Hospital Seoul
    Address 59, Daesagwan-ro (657 Hannam-dong), Yongsan-gu, Seoul, Korea

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 5
    Overall Recruitment Status Completed
    Date of First Enrollment 2016-01-08 Actual
    Target Number of Participant 145
    Primary Completion Date 2017-03-03 , Actual
    Study Completion Date 2017-03-03 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Soon Chun Hyang University Hospital Seoul
    Recruitment Status Completed
    Date of First Enrollment 2016-01-08 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Asan Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2016-06-09 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Kangbuk Samsung Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2016-03-08 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Dongguk University Ilsan Hospital
    Recruitment Status Completed
    Date of First Enrollment 2016-02-04 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Samsung Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2016-03-09 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name BMI Korea
    Organization Type Pharmaceutical Company
    Project ID HIRAX Study

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Soon Chun Hyang University Hospital Seoul
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    Hyaluronidase (HAase) has many uses in medicine, and reports suggested its effects perineal tissues during fetal passage through the vaginal canal. This study aimed to evaluate the effectiveness and safety of perineal HAase injection for reducing spontaneous perineal trauma, use of episiotomy, and perineal edema in vaginal deliveries.

  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose 
    Treatment
    Phase Phase3
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation Not Applicable
    Intervention Type Drug  
    Intervention Description 
    Nulliparous women planning for a vaginal delivery were recruited as subjects, and the enrolled participants were randomly assigned to the study group (HAase injection, 5,000 IU, n=74) or to the placebo group (normal saline injection, n=71). The study group was treated with 3 ml of 5,000 IU HAase (Hirax®, BMI Korea, Korea), while the placebo group was treated with 3 ml of normal saline, and with 3 ml of 1% lidocaine chlorohydrate solution. Both the active drug and placebo were injected at the perineal subcutaneous tissue in the center of the perineum and in each side (left and right) within 1 hour before fetal expulsion through the vagina.
    Number of Arms 2
    Arm 1

    Arm Label

    Study group (HAase injection, 5,000 IU)

    Target Number of Participant

    74

    Arm Type

    Experimental

    Arm Description

    • 3 ml of 5,000 IU HAase (Hirax®, BMI Korea, Korea) and with 3 ml of 1% lidocaine chlorohydrate solution
- Active drug was injected at the perineal subcutaneous tissue in the center of the perineum and in each side (left and right) within 1 hour before fetal expulsion through the vagina. Episiotomy was performed when it was indicated for either perineal rigidity or for the need to protect the fetus.
    Arm 2

    Arm Label

    Placebo group (Normal saline injection)

    Target Number of Participant

    71

    Arm Type

    Placebo comparator

    Arm Description

    • 3 ml of normal saline and with 3 ml of 1% lidocaine chlorohydrate solution
- Placebo was injected at the perineal subcutaneous tissue in the center of the perineum and in each side (left and right) within 1 hour before fetal expulsion through the vagina. Episiotomy was performed when it was indicated for either perineal rigidity or for the need to protect the fetus.

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (O00-O99)Pregnancy, childbirth and the puerperium 
       (O80.9)Single spontaneous delivery, unspecified 
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    19Year~40Year

    Description

    1.	Maternal age between 19 and 40 years old
2.	Gestational age between 37 weeks 0 days and 41 weeks 6 days, nulliparous with no previous record of vaginal birth
3.	Have never undergone surgery for the indication of cesarean section on the uterus and perineum
4.	Singleton pregnancy
5.	Do not have indications for emergency cesarean section during labor
6.	Never been exposed to hepatitis during pregnancy (German measles, Chickenpox, hepatitis C, Syphilis, HIV)
7.	Do not have uterine anomalies during antenatal consultation
8.	Voluntary written consent to participate in the Clinical trial
    Exclusion Criteria 
    1.	Multifetal gestations
2.	Fetal congenital anomaly
3.	Estimated birth weight over 4000 g
4.	Diagnosed with gestational diabetes or gestational hypertension (pregnancy addiction) at antenatal consultation
5.	Pregnant woman with family history of genetic disease
6.     Alleged maternal underlying disease such as  severe diabetes, hypertension, heart disease (congenital heart defects and venous congestion), epilepsy, kidney disease, autoimmune disease, active genital herpes infection, etc.
7.	Breast cancer, uterine cancer, or genital malignancy, or suspected to have a previous history of malignancy within 5 years.
8.	A serum protein level of less than 5.5 g / dl
9.	Abnormal placental implantation
10.	Hypersensitive conditions to hyaluronidase or bovine protein
11.	RH (-) blood type pregnancy
12.	the other tester judges that it is inappropriate for participation in the examination
    Healthy Volunteers No

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome 
    Perineal edema and severe perineal trauma (higher than second-degree laceration or episiotomy)
    Timepoint 
    VISIT 2 (1 hours after delivery), VISIT 3 (24 hours after delivery)
    Secondary Outcome(s) 1
    Outcome 
    Rate of performing episiotomy
    Timepoint 
    VISIT 2 (1 hours after delivery), VISIT 3 (24 hours after delivery)
    Secondary Outcome(s) 2
    Outcome 
    Adverse event
    Timepoint 
    VISIT 2 (1 hours after delivery), VISIT 3 (24 hours after delivery)
    Secondary Outcome(s) 3
    Outcome 
    Frequency of perineal laceration by category
    Timepoint 
    VISIT 2 (1 hours after delivery), VISIT 3 (24 hours after delivery)
    Secondary Outcome(s) 4
    Outcome 
    Degree of local edema
    Timepoint 
    VISIT 2 (1 hours after delivery), VISIT 3 (24 hours after delivery)
    Secondary Outcome(s) 5
    Outcome 
    Vital sign
    Timepoint 
    VISIT 2 (1 hours after delivery), VISIT 3 (24 hours after delivery)
    Secondary Outcome(s) 6
    Outcome 
    Lab test
    Timepoint 
    VISIT 2 (1 hours after delivery), VISIT 3 (24 hours after delivery)

  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Results Upload
    Final Enrollment Number 148
    Number of Publication 0
    Results Upload CSR for HIRAX_V4 1_Final_수정-20170628.pdf
    Date of Posting Results 2018/05/09
    Protocol URL or File Upload
    Brief Summary 
    In this study, we compared the incidence of episiotomy, severe perineal trauma, and improvement of perineal edema between HAase injection and placebo groups. Despite a lower proportion of episiotomy and severe perineal laceration (third- and fourth-degree lacerations) in the HAase injection group compared with the placebo group (52.7% vs 62.0% and 5.1% vs 9.1%, respectively), there was no statistically significant difference. But the women receiving HAase injection had significantly improved perineal edema at 24 hours compared with those receiving placebo (p=0.01). No serious adverse events were noted in both groups.

  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2018. 5
    Way of Sharing Available on Request
    (kychoi@schmc.ac.kr)
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