Vaginal acidity enhancement with a 3% acetic acid gel prior to misoprostol treatment for pregnancy termination in the midtrimester

Abd-El-Maeboud, Karim H. I.; Ghazy, Abbas A. S.; Ibrahim, Ahmed M. S.; Hassan, Nashwa E.; Elbohoty, Ahmed; Gamaleldin, Islam

doi:10.1016/j.ijgo.2012.06.017

Cited by 8 publications

(3 citation statements)

References 24 publications

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“…17 A clinical trial using AcA vaginally for acidification demonstrated 3% AcA to be safe and well tolerated. 18 This study assesses whether a double-blind randomized controlled feasibility trial of intravaginal prophylaxis management in RVVC individuals is appropriate in design and feasibility. Specifically, it investigated (1) recruitment and retention, (2) adherence to trial procedures and intervention protocol and (3) acceptability and suitability of outcome measures and trial procedures.…”

Section: Introductionmentioning

confidence: 99%

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Intravaginal Combination Therapy of Acetic and Lactic Acid in premenopausal women with recurrent vulvovaginal candidiasis: A randomized, double-blind placebo-controlled feasibility trial

Strydom,

Khan,

Walpola

et al. 2023

Womens Health (Lond Engl)

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Background: Recurrent vulvovaginal candidiasis management primarily entails azole therapy used as required or as an extended daily or weekly maintenance therapy for 6 months or more. Unfortunately, relapse within 3–6 months of ceasing maintenance therapy is experienced for more than half the patients, for whom indefinite treatment is required. Objectives: To explore the feasibility of trial design examining a prophylaxis treatment to prevent recurrent vulvovaginal candidiasis symptomatic episodes and reduce adverse effects. Study Design: A double-blinded randomized controlled feasibility trial was conducted in Australia. Women with recurrent vulvovaginal candidiasis were enrolled. Methods: An intravaginal prophylaxis application of lactic acid and acetic acid (Intravaginal Combination Therapy of Acetic and Lactic Acid) was compared with placebo. Primary outcomes comprised recruitment and retention, compliance to study medications and study assessments. Secondary outcomes included the reduction of symptomatic recurrence over the trial period and the acceptability, satisfaction, safety and tolerability of the intervention. The feasibility of quality-of-life measures was also explored. Results: Fifteen participants were enrolled and randomized (active = 9, placebo = 6). Consent rate was 23.4%. Eight participants were lost to follow-up (active = 5, placebo = 3). Forty-seven per cent of participants (n = 7) were 100% compliant with the intervention, six of which completed the trial with good assessment compliance. The blinding process was effective. The study demonstrated a reduction in relapse in both active and placebo groups with only four participants across both groups reporting symptomatic episodes while enrolled. The intervention demonstrated good tolerability. Quality-of-life data showed minimal variance with a high quality-of-life measure. Conclusion: This trial assesses the feasibility of conducting a large-scale study exploring the efficacy of the Intravaginal Combination Therapy of Acetic and Lactic Acid intravaginal intervention and hints on the importance of psychological support through appropriate disease-specific communication and clinical attention. Consideration of the reported recruitment challenges, the inclusion of suitable quality-of-life measures and digital data collection is warranted for adaptation to a fully powered trial.

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Section: Introductionmentioning

confidence: 99%

“… 17 A clinical trial using AcA vaginally for acidification demonstrated 3% AcA to be safe and well tolerated. 18 …”

Section: Introductionmentioning

confidence: 99%

Intravaginal Combination Therapy of Acetic and Lactic Acid in premenopausal women with recurrent vulvovaginal candidiasis: A randomized, double-blind placebo-controlled feasibility trial

Strydom,

Khan,

Walpola

et al. 2023

Womens Health (Lond Engl)

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“…1 Misoprostol cannot be completely dissolved in the vagina, and studies have shown that the effectiveness of the drug is related to the plasma level of the drug and reaching the highest level. Some studies have examined the factors affecting the absorption of this drug and mentioned the role of vaginal pH, 4,5 and others in the solubility and high plasma level of the drug. 6 Both of these items can be effective by a similar mechanism.…”

Section: Introductionmentioning

confidence: 99%

Effect of vaginal washing before Misoprostol insertion on cervical ripening before induction of labor: A randomized single‐blind clinical trial

Kabodmehri

Sharami

Milani

et al. 2022

Health Science Reports

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Background Vaginal pH is acidic in pregnancy, but there is no information about pH changes in pregnancy, and contradictory results have been reported from the effectiveness of Misoprostol at different vaginal pH. This study aimed to evaluate the effect of vaginal washing before Misoprostol insertion on cervical ripening before induction of labor in comparison with the control group. Methods This randomized single‐blind clinical trial was performed on 148 pregnant women who were candidates for induction of labor. Subjects were randomly divided into two groups of intervention (vaginal washing with 20 cc of normal saline 0.9% before Misoprostol insertion) and the control group (without vaginal washing). Vaginal pH and Bishop scores were measured before and after the intervention. The two groups were compared in demographic‐obstetric variables, the success rate of induction of labor, maternal and neonatal outcomes, and Misoprostol dose. Results After the intervention, there was no statistically significant difference between the pH before and after in the group with vaginal washing. There was no significant difference between the two groups in the type and duration of labor, and maternal and neonatal outcomes (P > .05). The frequency of normal delivery less than 12 hours in the intervention group was higher than in the control group. Although this difference was not statistically significant due to the small number of subjects, it is clinically significant. Conclusion The results of the present study showed that vaginal washing with normal saline before Misoprostol insertion for induction of labor did not affect the success of induction and duration of labor.

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Medical treatment for early fetal death (less than 24 weeks)

Lemmers

Verschoor

Kim

et al. 2019

Cochrane Database of Systematic Reviews

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Vaginal acidity enhancement with a 3% acetic acid gel prior to misoprostol treatment for pregnancy termination in the midtrimester

Abstract: A 3% acetic acid gel appears to be an effective and safe preparatory adjuvant to vaginal misoprostol treatment for midtrimester medical abortions, especially in women with a vaginal pH of 5 or higher. www.controlledtrials.com: ISRCTN75746444.

Cited by 8 publications

References 24 publications

Intravaginal Combination Therapy of Acetic and Lactic Acid in premenopausal women with recurrent vulvovaginal candidiasis: A randomized, double-blind placebo-controlled feasibility trial

Intravaginal Combination Therapy of Acetic and Lactic Acid in premenopausal women with recurrent vulvovaginal candidiasis: A randomized, double-blind placebo-controlled feasibility trial

Effect of vaginal washing before Misoprostol insertion on cervical ripening before induction of labor: A randomized single‐blind clinical trial

Medical treatment for early fetal death (less than 24 weeks)

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