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Postpartum Dyspareunia Resulting From Vaginal Atrophy

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ClinicalTrials.gov Identifier: NCT01319968
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Tracking Information
First Submitted Date March 20, 2011
First Posted Date March 22, 2011
Last Update Posted Date April 8, 2015
Study Start Date March 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2011)
Prevalence of vulvovaginal atrophy among puerperal women [ Time Frame: one year ]
Prevalence of vulvovaginal atrophy due to estrogen deficiency among puerperal women, according to cytological parameters.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01319968 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 20, 2011)
  • Prevalence of dyspareunia among women with puerperal vaginal atrophy. [ Time Frame: one year ]
    Prevalence and cause of dyspareunia among puerperal women with and without vaginal atrophy will be assesed
  • Effect of treatment with topical estrogen on dyspareunia. [ Time Frame: 2 months from begining of treatment ]
    The effect of vaginal estrogen cream on the prevalence of atrophy, its effect on postpartum dyspareunia and side effects.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Postpartum Dyspareunia Resulting From Vaginal Atrophy
Official Title 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Vaginal smears for cytology and pH measurment.
Sampling Method Probability Sample
Study Population 100 postpartum women attending the clinic for their postpartum visit
Condition
  • Vulvovaginal Atrophy
  • Dyspareunia Among Puerperal Women
Intervention 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
Study Groups/Cohorts 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 7, 2015)
117
Original Estimated Enrollment
 (submitted: March 20, 2011)
100
Actual Study Completion Date September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Healthy, puerperal women who will be willing to participate, over 18 years old.

Exclusion Criteria:

  • Patients with puerperal complications such as: bleeding, fever, endometritis.
  • Patients with significant systemic diseases.
  • Patients who conceive again during the study.
  • Patients who are not willing to participate
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01319968
Other Study ID Numbers MMC11030-2011kCTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Meir Medical Center
Study Sponsor Meir Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Ahinoam Lev-Sagie, MD Clalit Health Services
PRS Account Meir Medical Center
Verification Date April 2012