Postpartum Dyspareunia Resulting From Vaginal Atrophy
| Tracking Information | |||||
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| First Received Date ICMJE | March 20, 2011 | ||||
| Last Updated Date | January 30, 2013 | ||||
| Start Date ICMJE | March 2011 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prevalence of vulvovaginal atrophy among puerperal women [ Time Frame: one year ] [ Designated as safety issue: No ] Prevalence of vulvovaginal atrophy due to estrogen deficiency among puerperal women, according to cytological parameters. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01319968 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Postpartum Dyspareunia Resulting From Vaginal Atrophy | ||||
| Official Title ICMJE | Postpartum Dyspareunia Resulting From Vaginal Atrophy: Prevalence, Characteristics and Risk Factors | ||||
| Brief Summary | Postpartum dyspareunia (PD) is a recognized phenomenon: it is estimated that 50-60% of women have dyspareunia 6 to 7 weeks following delivery, and 33% and 17% will still report pain during intercourse three and six months after delivery, respectively. Studies that evaluated the prevalence and the causes for PD referred primarily to obstetric trauma, such as vaginal tears, episiotomy, the mode of repair and damage to the pelvic floor muscles as probable causes for PD. These studies did not refer to estrogen deficiency and the possible effect of breastfeeding on vaginal atrophy and its contribution to PD. Comparison between vaginal deliveries and cesarean sections revealed that there is no difference in the prevalence of PD between the two groups, and according to these findings it can be assumed that the mechanical trauma to the vagina and pelvic floor during delivery is not the main cause for the development of PD. Vaginal atrophy due to estrogen deficiency is a common cause for postmenopausal dyspareunia. With estrogen deficiency, profound changes occur in the vagina: vaginal mucosa becomes thin and pale or hyperemic and loose her flexibility. Blood flow decreases, normal vaginal discharge is reduced, and maturation of epithelial cells do not take place in the absence of estrogen. Women with estrogen deficiency may complain of dryness, pruritus, irritation, burning, dysuria, pain and dyspareunia. These changes are reversible by estrogen, given systemically or topically, and cause resolution of clinical findings, as well as disappearance of symptoms in several weeks. Similar to postmenopausal patients, breastfeeding women immediately after delivery, experience decline of estrogen levels, and this decline may persist as long as lactation is continued. Therefore, many women after delivery may experience vaginal atrophy due to transitional lack of estrogen. It is possible that this atrophy is the cause for the high rate of PD. Our clinical experience shows that many women present with postpartum dyspareunia with vaginal atrophy, and that vaginal atrophy is responsible for part or most of their complaints. Although most gynecologists recognize atrophy easily in menopausal women, vaginal atrophy is not recognized correctly in most puerperal patients and therefore do not receive attention and proper treatment. The aim of the study is to characterize the phenomenon of postpartum vaginal atrophy in terms of prevalence, risk factors and duration, and the association between vaginal atrophy and postpartum dyspareunia. We also intend to evaluate the effect of vaginal treatment with estriol cream 0.1% (Ovestin cream) on postpartum dyspareunia. The study will expand our knowledge regarding postpartum dyspareunia and will enable formulating recommendations for evaluation and treatment of PD. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Vaginal smears for cytology and pH measurment. |
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| Sampling Method | Probability Sample | ||||
| Study Population | 100 postpartum women attending the clinic for their postpartum visit |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Estriol 0.1% vaginal cream
Patients with both vulvovaginal atrophy (according to cytologic criteria) and dyspareunia will apply 0.5 ml of the cream (0.5 mg) to the vulvar vestibule once daily for one month and will return for check-up visit. In case both atrophy and dyspareunia will resolve, treatment with the cream will be continued 3 times a week.
Other Name: Ovestin vaginal cream |
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| Study Group/Cohort (s) | Postpartum patients
100 postpartum women attending the clinic for their postpartum visit will be evaluated for vaginal atrophy, vaginal symptoms and dyspareunia.
Intervention: Drug: Estriol 0.1% vaginal cream |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | March 2013 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01319968 | ||||
| Other Study ID Numbers ICMJE | MMC11030-2011kCTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Meir Medical Center | ||||
| Study Sponsor ICMJE | Meir Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Meir Medical Center | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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