None listed
Conditions
Interventions
Drug : 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
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 befor
Sponsors
Soon Chun Hyang University Hospital Seoul
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perineal edema and severe perineal trauma (higher than second-degree laceration or episiotomy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of performing episiotomy;Adverse event;Frequency of perineal laceration by category;Degree of local edema;Vital sign;Lab test | — |
Countries
Korea, Republic of
Contacts
Public ContactGyuyeon Choi
Soon Chun Hyang University Hospital Seoul
Outcome results
None listed