Dataset Information

A pilot randomized controlled trial of vaginal estrogen on postpartum atrophy, perineal pain, and sexual function.

ABSTRACT:

Introduction and hypothesis

Vulvovaginal symptoms following perineal laceration may be worsened by atrophy related to decreased estrogen. Our objective was to evaluate the effect of local estrogen therapy in this setting.

Methods

We conducted a single-center, pilot, randomized, placebo-controlled trial of local estradiol in primiparous women with a second-degree or greater perineal laceration following a term vaginal delivery. Participants were randomized to twice weekly estradiol or placebo cream from delivery through 3 months postpartum. The primary outcome was a validated measure of vulvovaginal symptoms at 12 weeks postpartum. Secondary outcomes included measures of perineal pain, quality of life, sexual function, ease of use, likelihood of continued use, and adverse events.

Results

We planned to enroll 70 women; however, due to human subjects research restrictions related to the COVID-19 pandemic, enrollment was stopped early. A total of 59 women were randomized, 31 to the estradiol group and 28 to the placebo group. Nearly all participants (95%) were followed through 12 weeks with suggestion of marginal improvement in Vulvar Assessment Scale scores [-0.10; 90% CI = (-0.20, 0.01)] in those randomized to estradiol compared to placebo. Local estradiol was not associated with improvement in other measures, and only one non-serious adverse event was observed.

Conclusions

In primiparous women with a perineal laceration, use of local estradiol showed minimal clinical benefit in vulvovaginal atrophy and related symptoms but appears to be acceptable and safe for postpartum use. Larger adequately powered trials enrolling a diverse group of postpartum women are needed to affirm these findings.

SUBMITTER: Smith PE

PROVIDER: S-EPMC9020152 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

A pilot randomized controlled trial of vaginal estrogen on postpartum atrophy, perineal pain, and sexual function.

Smith Pamela E PE McLaughlin Eric M EM Pandya Lopa K LK Hade Erinn M EM Lynch Courtney D CD Hudson Catherine O CO

International urogynecology journal 20220420 12

<h4>Introduction and hypothesis</h4>Vulvovaginal symptoms following perineal laceration may be worsened by atrophy related to decreased estrogen. Our objective was to evaluate the effect of local estrogen therapy in this setting.<h4>Methods</h4>We conducted a single-center, pilot, randomized, placebo-controlled trial of local estradiol in primiparous women with a second-degree or greater perineal laceration following a term vaginal delivery. Participants were randomized to twice weekly estradiol ...[more]

PMID: 35441854

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Project description:ObjectiveSexuality is an important aspect of human identity and contributes significantly to the quality of life in women as well as in men. Impairment in sexual health after vaginal delivery is a major concern for many women. We aimed to examine the association between degree of perineal tear and sexual function 12 months postpartum.DesignA prospective cohort study SETTING: Four Danish hospitals between July 2015 and January 2019 PARTICIPANTS: A total of 554 primiparous women: 191 with no/labia/first-degree tears, 189 with second-degree tears and 174 with third-degree/fourth-degree tears. Baseline data were obtained 2 weeks postpartum by a questionnaire and a clinical examination. Sexual function was evaluated 12 months postpartum by an electronic questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)) and a clinical examination.Primary outcome measuresTotal PISQ-12 score and dyspareunia RESULTS: Episiotomy was performed in 54 cases and 95 women had an operative vaginal delivery. The proportion of women with dyspareunia was 25%, 38% and 53% of women with no/labia/first-degree, second-degree or third-degree/fourth-degree tears, respectively.Compared with women with no/labia/first-degree tears, women with second-degree or third-degree/fourth-degree tears had a higher risk of dyspareunia (adjusted relative risk (aRR) 2.05; 95% CI 1.51 to 2.78 and aRR 2.09; 95% CI 1.55 to 2.81, respectively). Women with third-degree/fourth-degree tears had a higher mean PISQ-12 score (12.2) than women with no/labia/first-degree tears (10.4).ConclusionsImpairment of sexual health is common among primiparous women after vaginal delivery. At 12 months postpartum, more than half of the women with a third-degree/fourth-degree tear experienced dyspareunia. Women delivering with no/labia/first-degree tears reported the best outcomes overall. Thus, it is important to minimise the extent of perineal trauma and to counsel about sexuality during and after pregnancy.

Project description:IntroductionPostnatal perineal pain is prevalent following childbirth and can impact women both physically and emotionally. The aim of the study was to study the effect of collegial midwifery assistance on perineal pain and pain medication 1 month after birth and to investigate the associations between the type of tear and perineal pain, satisfaction with healing, and resumption of intercourse.Material and methodsA follow-up questionnaire was sent 1 month postpartum to women with a first spontaneous vaginal birth participating in a randomized controlled trial (Oneplus trial). Data were collected from December 2019 to May 2020. Differences in perineal pain between women attended by one or two midwives were analyzed according to intention-to-treat using bivariate analyses. Associations between the type of tear and perineal pain, satisfaction with healing, and resumption of sexual intercourse were investigated using univariable and multivariable logistic regression. The category no tear/first-degree tear was compared separately to each of the other tear categories.Trial registration numberClinicalTrials.gov, NCT03770962.ResultsOut of 2233 women, 1762 responded within 30-60 days postpartum. Of women in the no tear/first-degree tear category, 27.7% reported perineal pain during the past week, in contrast to women with OASI, where 64.2% reported perineal pain. Women with OASI experienced the highest odds of perineal pain (aOR 4.51, 95% CI 2.72-7.47) compared to those with no tear/first-degree tear, followed by women with major second-degree tears (aOR 1.87, 95% CI 1.45-2.41), women with an episiotomy (aOR 1.78, 95% CI 1.11-2.87), and those with minor second-degree tears (aOR 1.43, 95% CI 1.06-1.94). Women with episiotomy reported the highest odds ratios for dissatisfaction with tear healing (aOR 3.48, 95% CI 1.92-6.31). No significant differences in perineal pain and pain medication were observed between women allocated to collegial midwifery assistance and those allocated to standard care.ConclusionsWomen with OASI reported the highest odds of perineal pain 30-60 days after birth compared to women with no tear or first-degree tear, followed by women with major second-degree tears. Women subjected to an episiotomy reported highest odds ratios of dissatisfaction with tear healing.

Project description:ObjectiveTo evaluate the reduction of perineal pain after vaginal deliveries by capacitive resistive radiofrequency therapy (RF).MethodsWe conducted a double-blind randomized study in University Hospital Centre in France. We included women presenting either perineal tears or an episiotomy after vaginal delivery (instrumental assisted or not). The participants were randomly assigned to RF or not at day 1 and day 2 postpartum. The primary outcome was pain evaluated as visual analog scale (VAS) score >4 at rest on day 2 after the treatment. Secondary outcomes included discomfort and pain while walking and seating two days after treatment, type of pain two days after treatment and analgesics intake two days after treatment, sexual intercourse retake and painful of intercourse were also assessed by phone call 30 days after delivery. We performed univariate analysis and multivariable regressions adjusting on the value of the outcome at baseline to improve precision of the estimated intervention effect.ResultsBetween June 1, 2017 and October 8, 2017, the RF group included 29 women compared with 31 women in the group without RF. There was no significant difference on VAS >4 between the two groups (13.8% vs. 9.7% p = 0.69; difference = 4.1%, 95%CI -12.2%- 20.4%); consumption of paracetamol was lower in the RF group (978.3 mg (sd = 804.5) vs 1703.7 mg (sd = 1381.6), p = 0.035; difference = -725.3 mg, 95%CI -1359.6 - -91.3). Multivariate analysis showed no association between RF and pain. Nevertheless, we found an association between RF and discomfort while walking (adjusted OR 0.24, 95% CI 0.07-0.90; p = 0.03).ConclusionVAS>4 at day 2 was not different in the experimental and the control groups but RF was associated with less perineal discomfort while walking and lower consumption of paracetamol after delivery.Clinical trial registrationsThe study was registered in the Clinical Government trial (https://clinicaltrials.gov/ct2/show/NCT03172286?term=bretelle&rank=2) under the number NCT03172286.

Project description:BackgroundMaternal Group B Streptococcus (GBS) colonization is influenced by many factors but results are inconsistent. Consideration of antenatal risk factors may help inform decision making on GBS microbiological culture screening where universal screening is not standard of care. We sought to identify independent predictors of GBS colonization at 34-37 weeks gestation incorporating vaginal symptoms, perineal hygiene measures, sexual activity, and a potential novel factor, constipation.MethodsIn this prospective cross-sectional study, 573 women at 34-37 weeks gestation had an ano-vaginal swab taken and sent for selective culture for GBS. Women were asked about vaginal bleeding, discharge, irritation and candidiasis, antibiotic use during pregnancy, ano-vaginal hygiene practices such as douching and perineal cleansing after toileting, sexual intercourse related activities, and a potential novel factor for GBS carriage, constipation. Maternal basic demographics and obstetric-related characteristics were also collected. Bivariate analyses were performed to identify associates of GBS colonization. All variables with p < 0.05 found on bivariate analysis were then included into a model for multivariable binary logistic regression analysis to identify independent risk factors for GBS colonization.ResultsGBS colonization was found in 235/573 (41.0%) of participants. Twenty six independent variables were considered for bivariate analysis. Eight were found to have p < 0.05. Following adjusted analysis, six independent predictors of GBS colonization were identified: ethnicity, previous neonatal GBS prophylaxis, antenatal vaginal irritation, antibiotic use, recent panty liner use, and frequency of sexual intercourse. Vaginal discharge and perineal cleansing were not associated after adjustment. Recent douching and constipation were not associated on bivariate analysis.ConclusionThe identification of independent predictors of GBS colonization in late pregnancy may inform the woman and care provider in their shared decision making for microbiological screening at 35-38 weeks gestation in locations where universal GBS screening is not standard of care.Ethics oversightThis study was approved by the Medical Ethics Committee of University Malaya Medical Centre (UMMC) on August 9, 2022, reference number 2022328-11120.

Dataset Information

A pilot randomized controlled trial of vaginal estrogen on postpartum atrophy, perineal pain, and sexual function.

Introduction and hypothesis

Methods

Results

Conclusions

Publications

A pilot randomized controlled trial of vaginal estrogen on postpartum atrophy, perineal pain, and sexual function.

Similar Datasets

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