Clinical Trial to evalute the Efficacy and Safety of Hyaluronidase for Vaginal Delivery in Nulliparous Wome

Not Applicable

Completed

Conditions: Pregnancy, childbirth and the puerperium

Registration Number: KCT0002855

Lead Sponsor: Soon Chun Hyang University Hospital Seoul

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 148

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

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