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Combined oral contraceptive pill-exposure alone does not reduce the risk of bacterial vaginosis recurrence in a pilot randomised controlled trial.

ABSTRACT: We conducted a pilot open-label randomised controlled trial of combined (oestrogen-progesterone) oral contraceptive pill (COCP)-exposure aimed to examine its effect on BV-recurrence following first-line antibiotics compared to antibiotics alone. Ninety-five women with symptomatic BV were prescribed antibiotic therapy, randomised to COCP-exposure (intervention) or current non-hormonal contraceptive practices (control) and followed monthly for six-months or until BV-recurrence. Modified intention-to-treat methods requiring either ?1 clinical (primary/Amsel-outcome) or ?1 microbiological (secondary/Nugent-outcome) BV-recurrence assessment were applied to determine cumulative recurrence rates. Secondary Cox regression analyses assessed factors associated with recurrence in all women. 92/95 women randomised provided baseline requirements. BV-recurrence rates were similar in women randomised to the COCP (primary/Amsel-outcome: 10/100PY, 95%CI: 6,19/100PY) compared to controls (14/100PY, 95%CI: 9, 21/100PY, p?=?0.471). In secondary analyses sex with the same pre-treatment regular sexual partner (RSP; Amsel: Adjusted Hazard Ratio [AHR]?=?3.13, 95%CI: 1.41, 6.94, p?=?0.005; Nugent: AHR?=?2.97, 95%CI: 1.49, 5.83, p?=?0.002) and BV-history (Amsel: AHR?=?3.03, 95%CI: 1.14, 6.28; Nugent: AHR?=?2.78, 95%CI: 1.22, 6.33) were associated with increased BV-recurrence. This pilot RCT of COCP-exposure did not improve BV cure but found sex with an RSP and BV-history were associated with recurrence, although impacted by sample size and attrition. These data indicate reinfection from an untreated RSP and persistence of BV-associated bacteria are integral to the pathogenesis of recurrence and may overwhelm potential beneficial effects of hormonal contraception on the vaginal microbiota.

SUBMITTER: Vodstrcil LA

PROVIDER: S-EPMC6401172 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Combined oral contraceptive pill-exposure alone does not reduce the risk of bacterial vaginosis recurrence in a pilot randomised controlled trial.

Vodstrcil Lenka A LA Plummer Ms Erica ME Fairley Christopher K CK Tachedjian Gilda G Law Matthew G MG Hocking Jane S JS Worthington Ms Karen MK Grant Ms Mieken MM Okoko Nita N Bradshaw Catriona S CS

Scientific reports 20190305 1

We conducted a pilot open-label randomised controlled trial of combined (oestrogen-progesterone) oral contraceptive pill (COCP)-exposure aimed to examine its effect on BV-recurrence following first-line antibiotics compared to antibiotics alone. Ninety-five women with symptomatic BV were prescribed antibiotic therapy, randomised to COCP-exposure (intervention) or current non-hormonal contraceptive practices (control) and followed monthly for six-months or until BV-recurrence. Modified intention- ...[more]

PMID: 30837554

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Project description:ObjectivesTo compare agreement between self-reported height, weight and blood pressure measurements submitted to an online contraceptive service with researcher-measured values and document strategies used for self-reporting.DesignAn observational study.SettingAn online sexual health service which provided the combined oral contraceptive pill, free of charge, to users in Southeast London, England.ParticipantsBetween August 2017 and August 2019, 365 participants were recruited.Primary and secondary outcome measuresThe primary outcome, for which the study was powered, was the agreement between self-reported and researcher-measured body mass index (BMI) and blood pressure measurements, compared using kappa coefficients. Secondary measures of agreement included sensitivity, specificity and Bland Altman plots. The study also describes strategies used for self-reporting and classifies their clinical appropriateness.Results327 participants fully described their process of blood pressure measurement with 296 (90.5%) classified as clinically appropriate. Agreement between self-reported and researcher-measured BMI was substantial (0.72 (95% CI 0.42 to 1.0)), but poor for blood pressure (0.06 (95% CI -0.11 to 0.23)). Self-reported height and weight readings identified 80.0% (95% CI 28.4 to 99.5) of individuals with a researcher-measured high BMI (≥than 35 kg/m2) and 9.1% (95% CI 0.23 to 41.3) of participants with a researcher-measured high blood pressure (≥140/90 mm Hg).ConclusionIn this study, while self-reported BMI was found to have substantial agreement with researcher-measured BMI, self-reported blood pressure was shown to have poor agreement with researcher-measured blood pressure. This may be due to the inherent variability of blood pressure, overdiagnosis of hypertension by researchers due to 'white coat syndrome' or inaccurate self-reporting. Strategies to improve self-reporting of blood pressure for remote prescription of the combined pill are needed.

Dataset Information

Combined oral contraceptive pill-exposure alone does not reduce the risk of bacterial vaginosis recurrence in a pilot randomised controlled trial.

Publications

Combined oral contraceptive pill-exposure alone does not reduce the risk of bacterial vaginosis recurrence in a pilot randomised controlled trial.

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