Clinical trial NCT01319968: Postpartum Dyspareunia Resulting From Vaginal Atrophy
Official title: Postpartum Dyspareunia Resulting From Vaginal Atrophy: Prevalence, Characteristics and Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvovaginal Atrophy
Dyspareunia Among Puerperal Women
Keywords: Postpartum dyspareunia
Vaginal atrophy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 postpartum women attending the clinic for their postpartum visit

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.


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

Primary outcomes:
measure: Prevalence of vulvovaginal atrophy among puerperal women
timeFrame: one year
Secondary outcomes:
measure: Prevalence of dyspareunia among women with puerperal vaginal atrophy.
timeFrame: one year
measure: Effect of treatment with topical estrogen on dyspareunia.
timeFrame: 2 months from begining of treatment
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Clalit Women's Health Center
city: Modiin
country: Israel
facility: Clalit Women's Health Center
Study officials:
affiliation: Clalit Health Services
name: Ahinoam Lev-Sagie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wisniewski PM, Wilkinson EJ. Postpartum vaginal atrophy. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 2):1249-54. doi: 10.1016/s0002-9378(12)90737-1.
citation: Signorello LB, Harlow BL, Chekos AK, Repke JT. Postpartum sexual functioning and its relationship to perineal trauma: a retrospective cohort study of primiparous women. Am J Obstet Gynecol. 2001 Apr;184(5):881-8; discussion 888-90. doi: 10.1067/mob.2001.113855.
citation: Carroli G, Mignini L. Episiotomy for vaginal birth. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD000081. doi: 10.1002/14651858.CD000081.pub2.