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Postpartum Dyspareunia Resulting From Vaginal Atrophy

NCT01319968 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 117

Last updated 2015-04-08

No results posted yet for this study

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.

Conditions

  • Vulvovaginal Atrophy
  • Dyspareunia Among Puerperal Women

Interventions

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.

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Ahinoam Lev-Sagie, MD · Clalit Health Services

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01319968 on ClinicalTrials.gov