Trial reportYonsei medical journal2020
Randomized, Double-Blind, Placebo-Controlled Trial on the Efficacy of Hyaluronidase in Preventing Perineal Trauma in Nulliparous Women.
Trial report in Yonsei medical journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07705165 (A Randomized, Split Body, Evaluator-blinded, Trial on the Effect of Tergase Injection), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Split Body, Evaluator-blinded, Trial on the Effect of Tergase Injection (Berahyaluronidase Alfa) on Reducing Edema After Both Total Knee Arthroplasty
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.
- Hyaluronidase for reducing perineal trauma.The Cochrane database of systematic reviews · 2024Pooled it
- A Simulation Analysis of Maternal Pelvic Floor Muscle.International journal of environmental research and public health · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeHyaluronidase (HAase) has many uses in medicine, and reports suggest that it affects perineal tissue during fetal passage through the vaginal canal. However, its potential use for preventing perineal trauma has yet to be determined. This study sought to evaluate the efficacy and safety of perineal HAase injections in reducing perineal trauma during vaginal delivery. MATERIALS AND
methodsA multi-center, double-blind, placebo-controlled, randomized study was conducted from January 2016 to March 2017. Nulliparous women who planned to undergo vaginal delivery were recruited, and the enrolled women were randomly assigned to the HAase injection group (HAase injection, 5000 IU, n=75) or the control group (normal saline injection, n=73). The degree of perineal laceration, rate of episiotomy, and grade of perineal edema at 1 hour and 24 hours after spontaneous vaginal delivery were compared between the two groups.
resultsA total of 148 women who underwent vaginal delivery were recruited. No significant differences were observed between the HAase injection and control groups in the rates of perineal laceration (
conclusionHAase injections in nulliparous women afforded no reductions in the rates of perineal lacerations and episiotomy. However, the use of perineal HAase injections did reduce perineal edema without severe adverse events.
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Registered trials
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