Postpartum Dyspareunia Resulting From Vaginal Atrophy

Completed

• Conditions: Dyspareunia Among Puerperal Women; Vulvovaginal Atrophy
• Interventions: Drug: Estriol 0.1% vaginal cream

• Registration Number: NCT01319968
• Lead Sponsor: Meir Medical Center

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 available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-20
• Study First Submitted QC: 2011-03-20
• Study First Posted: 2011-03-22
• Status Verified: 2012-04
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postpartum patients	Estriol 0.1% vaginal cream	100 postpartum women attending the clinic for their postpartum visit will be evaluated for vaginal atrophy, vaginal symptoms and dyspareunia.

Primary Outcome Measures

Name	Time	Method
Prevalence of vulvovaginal atrophy among puerperal women	one year	Prevalence of vulvovaginal atrophy due to estrogen deficiency among puerperal women, according to cytological parameters.

Secondary Outcome Measures

Name	Time	Method
Effect of treatment with topical estrogen on dyspareunia.	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.
Prevalence of dyspareunia among women with puerperal vaginal atrophy.	one year	Prevalence and cause of dyspareunia among puerperal women with and without vaginal atrophy will be assesed

Trial Locations

Locations (1)

Clalit Women's Health Center; 🇮🇱 Modiin, Israel