Vagina; Anomaly, Puerperium; Disease, Sexual Dysfunction
Conditions
Keywords
Puerperium
Brief summary
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.
Interventions
DRUGVaginal gel HYALOGYN®
Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks
BEHAVIORALExpectant management
Expectant management for 12 consecutive weeks
Sponsors
Ospedale Policlinico San Martino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women from 18 to 40 years old; * Women in the puerperium period (after vaginal delivery or cesarean section); * Women that are breast-feeding, that are not breast-feeding or that are breast-feeding partially;
Exclusion criteria
* Allergy to hyaluronic acid gel; * Women non-Italian speaking; * Women with signs of vaginal infection; * Women with a history of cancer of any site with recent genital bleeding of unknown origin; and patients with acute hepatopathy, embolic disorders, severe primary disease of kidney; * Women who are attending or have attended other clinical trials within previous two weeks; * Women with mental disorder and no insight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of sexual function by FSFI | At baseline; 12 weeks |
Countries
Italy
Outcome results
None listed