Postpartum Dyspareunia Resulting From Vaginal Atrophy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01319968
First received: March 20, 2011
Last updated: January 30, 2013
Last verified: April 2012
  Purpose

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.


Condition Intervention
Vulvovaginal Atrophy
Dyspareunia Among Puerperal Women
Drug: Estriol 0.1% vaginal cream

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Postpartum Dyspareunia Resulting From Vaginal Atrophy: Prevalence, Characteristics and Risk Factors

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Prevalence of dyspareunia among women with puerperal vaginal atrophy. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The effect of vaginal estrogen cream on the prevalence of atrophy, its effect on postpartum dyspareunia and side effects.


Biospecimen Retention:   Samples Without DNA

Vaginal smears for cytology and pH measurment.


Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Postpartum patients
100 postpartum women attending the clinic for their postpartum visit will be evaluated for vaginal atrophy, vaginal symptoms and dyspareunia.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

100 postpartum women attending the clinic for their postpartum visit

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319968

Contacts
Contact: Ahinoam Lev-Sagie, MD 972-2-5889500 ext 3 levsagie@netvision.net.il

Locations
Israel
Clalit Women's Health Center Recruiting
Jerusalem, Israel
Contact: Ahinoam Lev Sagie, MD         
Clalit Women's Health Center Recruiting
Modiin, Israel
Contact: Hagai Amsalem, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Ahinoam Lev-Sagie, MD Clalit Health Services
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01319968     History of Changes
Other Study ID Numbers: MMC11030-2011kCTIL
Study First Received: March 20, 2011
Last Updated: January 30, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Postpartum dyspareunia
Vaginal atrophy

Additional relevant MeSH terms:
Atrophy
Dyspareunia
Pathological Conditions, Anatomical
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 02, 2014