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During postpartum and lactation, vaginal epithelium tends to have an impaired degree of hydration and lubrication. This may lead to vaginal dryness, burning sensation dyspareunia or itching, which negatively affect the sexual function of puerperal women.
This study aimed to evaluate the efficacy of HYDEAL-D® vaginal gel (HYALOGYN®, Fidia Farmaceutici, Abano Terme, Italy) application on promoting the restoration of sexual function in the postpartum period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group receiving HYALOGYN® | Experimental |
| |
| Control group undergoing expectant management | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal gel HYALOGYN® | Drug | Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of sexual function by FSFI | At baseline; 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabio Barra, MD | Ospedale San Martino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Policlinico San Martino | Genova | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34477473 | Result | Gustavino C, Sala P, Cusini N, Gravina B, Ronzini C, Marcolin D, Vellone VG, Paudice M, Nappi R, Costantini S, Ferrero S, Barra F. Efficacy and safety of prolonged-release hyaluronic acid derivative vaginal application in the postpartum period: a prospective randomised clinical trial. Ann Med. 2021 Dec;53(1):1589-1597. doi: 10.1080/07853890.2021.1974083. |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D011644 | Puerperal Disorders |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Expectant management | Behavioral | Expectant management for 12 consecutive weeks |
|
| Urogenital Diseases |
| D000091662 | Genital Diseases |