Objective: To create a reference curve for postvoid residual volume (PVRV) in asymptomatic postpartum women who are at low risk of developing postpartum urinary retention (PUR), a well-known complication in the immediate postpartum period.
Methods: This is a prospective observational study measuring PVRV after uncomplicated vaginal delivery. PVRV was assessed by transabdominal ultrasound using a portable ultrasound scanner within the first 26 h after delivery (PVRV 1) and on the day of discharge (day 2 or 3 postpartum) (PVRV 2). A PVRV of 150 mL or more was defined as the cut-off value for covert PUR.
Results: The prevalence of covert PUR was 7.1%. Primiparity, duration of second stage, and obstetric injury were correlated with higher PVRV 1. The median PVRV 1 was 21 mL and PVRV 2 was 11 mL. The subgroup of nulliparous women had a significantly higher PVRV 1 compared with multiparous women. At discharge, the majority (99.1%) of women had a PVRV of less than 150 mL.
Conclusion: Asymptomatic women were at low risk of developing PUR. However, women with a prolonged second stage may benefit from a routine postpartum assessment. Our results allow for a better understanding of PVRV in the early postpartum period.
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http://dx.doi.org/10.1002/ijgo.14668 | DOI Listing |
Clin Infect Dis
November 2024
Clinical Development, Sanofi Vaccines, Singapore.
Background: A next-generation, serum-free, highly purified Vero cell rabies vaccine, PVRV-NG2, is in development.
Methods: This multicenter, observer-blind, phase 3 study evaluated the immunogenicity and safety of PVRV-NG2, compared with two licensed rabies vaccines (purified Vero cell rabies vaccine [PVRV] and human diploid cell vaccine [HDCV]), as a pre-exposure prophylaxis (PrEP) regimen. Participants were randomized 3:1:1 to PVRV-NG2, PVRV, or HDCV, as a three-dose (Cohort 1; children and adults; day [D] 0, D7, and D28) or two-dose (Cohort 2; adults; D0 and D7) PrEP regimen.
Open Forum Infect Dis
November 2024
Global Clinical Development Strategy, Sanofi, Marcy l'Étoile, France.
Background: A serum-free, highly purified Vero rabies vaccine-next generation (PVRV-NG2) is under development. We conducted a phase III trial to describe the safety and immunogenicity profile of PVRV-NG2 compared with those of licensed purified Vero rabies vaccine (PVRV) in a simulated rabies postexposure prophylaxis (PEP) Zagreb regimen in Thailand.
Methods: Healthy adults aged ≥18 years (n = 201) were randomized in a 2:1 ratio to receive PVRV-NG2 or PVRV in a rabies PEP Zagreb (days 0, 7, 21 [2-1-1]) regimen, with concomitant human rabies immunoglobulin (HRIG) at day 0.
Travel Med Infect Dis
July 2024
Division of Infectious Disease Management, Chinese Center for Disease Control and Prevention, Beijing, 102206, China.
Background: The 4-dose Essen intramuscular (IM) regimen for rabies post-exposure prophylaxis (PEP) has been recommended by Advisory Committee on Immunization Practices (ACIP) and World Health Organization (WHO), but the large-sample clinical evidence is still limited.
Method: Rabies virus neutralizing antibodies of 11,752 patients were detected from 409 rabies prevention clinics in 27 provinces in China. Patients with serum collected before or no later than 1 h after injection on the day of the fifth dose (day 28) of 5-dose Essen regimen were included in Group A to observe the immune efficacy of 4-dose Essen IM regimen, and patients with serum collected 14-28 days after injection of the fifth dose were included in Group B to observe the immune efficacy of 5-dose Essen IM regimen.
Clin Infect Dis
June 2024
Global Clinical Immunology, Sanofi, Campus Mérieux, Marcy l'Etoile, France.
Background: A next-generation Vero cell rabies vaccine (PVRV-NG2) was developed using the same Pitman-Moore strain as in the licensed purified Vero cell vaccine (PVRV; Verorab) and the human diploid cell vaccine (HDCV; Imovax Rabies®).
Methods: This dual-center, modified, double-blind, phase 3 study evaluated the immunogenic non-inferiority and safety of PVRV-NG2 with and without concomitant intramuscular human rabies immunoglobulin (HRIG) versus PVRV + HRIG and HDCV + HRIG in a simulated post-exposure prophylaxis (PEP) regimen. Healthy adults ≥18 years old (N = 640) were randomized 3:1:1:1 to PVRV-NG2 + HRIG, PVRV + HRIG, HDCV + HRIG, or PVRV-NG2 alone (administered as single vaccine injections on days [D] 0, D3, D7, D14, and 28, with HRIG on D0 in applicable groups).
J Bone Joint Surg Am
April 2024
Bone and Joint Institute, Hartford Hospital, Hartford, Connecticut.
Background: As total joint arthroplasty (TJA) moves to the outpatient setting, it is becoming clear that postoperative urinary retention (POUR) is a potential impediment to same-day discharge. Although risk factors for POUR have been widely studied, the lack of their clinical utility warrants investigation of specific preoperative factors that can assist in surgical planning and patient optimization. The purpose of the current study was to determine whether preoperative symptom surveys and bladder scanning are useful tools in identifying POUR risk.
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