Please cite this paper as: Bellad M, Tara D, Ganachari M, Mallapur M, Goudar S, Kodkany B, Sloan N, Derman R. Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double‐blind randomised controlled trial. BJOG 2012;119:975–986. Objective Sublingual misoprostol produces a rapid peak concentration, and is more effective than oral administration. We compared the postpartum measured blood loss with 400 μg powdered sublingual misoprostol and after standard care using 10 iu intramuscular (IM) oxytocin. Design Double‐blind randomised controlled trial. Setting A teaching hospital: J N Medical College, Belgaum, India. Sample A cohort of 652 consenting eligible pregnant women admitted to the labour room. Methods Subjects were assigned to receive the study medications and placebos within 1 minute of clamping and cutting the cord by computer‐generated randomisation. Chi‐square and bootstrapped Student’s t‐tests were used to test categorical and continuous outcomes, respectively. Main outcome measures Measured mean postpartum blood loss and haemorrhage (PPH, loss ≥500 ml), >10% pre‐ to post‐partum decline in haemoglobin, and reported side effects. Results The mean blood loss with sublingual misoprostol was 192 ± 124 ml (n = 321) and 366 ± 136 ml with oxytocin IM (n = 331, P ≤ 0.001). The incidence of PPH was 3.1% with misoprostol and 9.1% with oxytocin (P = 0.002). No woman lost ≥1000 ml of blood. We observed that 9.7% and 45.6% of women experienced a haemoglobin decline of >10% after receiving misoprostol and oxytocin, respectively (P ≤ 0.001). Side effects were significantly greater in the misoprostol group than in the oxytocin group. Conclusion Unlike other studies, this trial found sublingual misoprostol more effective than intramuscular oxytocin in reducing PPH, with only transient side effects being greater in the misoprostol group. The sublingual mode and/or powdered formulation may increase the effectiveness of misoprostol, and render it superior to injectable oxytocin for the prevention of PPH. Further research is needed to confirm these results.
Background Anaemia is a worldwide problem and iron deficiency is the most common cause. In pregnancy, anaemia increases the risk of adverse maternal, foetal and neonatal outcomes. India’s anaemia rate is among the highest in the world with India’s National Family Health Survey indicating over 50% of pregnant women were affected by anaemia. India’s Anaemia Mukt Bharat-Intensified National Iron Plus Initiative aims to reduce the prevalence of anaemia among reproductive-age women, adolescents and children by 3% per year and facilitate the achievement of a Global World Health Assembly 2025 objective to achieve a 50% reduction of anaemia among women of reproductive age. However, preliminary results of the NFHS-5 survey completed in 2020 indicate that anaemia rates are increasing in some states and these targets are unlikely to be achieved. With oral iron being the first-line treatment for iron deficiency anaemia (IDA) in pregnancy, these results are likely to be impacted by the side effects, poor adherence to tablet ingestion and low therapeutic impact of oral iron. These reports suggest a new approach to treating IDA, specifically the importance of single-dose intravenous iron infusions, may be the key to India effectively reaching its targets for anaemia reduction. Methods This 3-arm, randomized controlled trial is powered to report two primary outcomes. The first is to assess whether a single dose of two different intravenous formulations administered early in the second trimester of pregnancy to women with moderate IDA will result in a higher percentage of participants achieving a normal for pregnancy Hb concentration at 30–34 weeks’ gestation or just prior to delivery when compared to participants taking standard doses of oral iron. The second is a clinical outcome of low birth weight (LBW) (< 2500 g), with a hypothesis that the risk of LBW delivery will be lower in the intravenous iron arms when compared to the oral iron arm. Discussion The RAPIDIRON trial will provide evidence to determine if a single-dose intravenous iron infusion is more effective and economically feasible in reducing IDA in pregnancy than the current standard of care. Trial registration Clinical Trials Registry – India CTRI/2020/09/027730. Registered on 10 September 2020, http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=46801&EncHid=&userName=anemia%20in%20pregnancy
Background. A Nugent score > 7 has been defined as the gold standard for the diagnosis for bacterial vaginosis (BV), though it is resource intensive and impractical as point of care testing. We sought to determine if colorimetric assessment of vaginal pH can accurately predict the occurrence of BV. Methods. We performed a planned subanalysis of 1,216 pregnant women between 13 0/7 and 19 6/7 weeks who underwent vaginal examination as part of a randomized controlled trial. Using a standardized technique, specimens were obtained for colorimetric assessment and two separate slides for Gram staining. These slides were subsequently evaluated by two independent blinded microbiologists for Nugent scoring. Results. Interrater reliability of the interpretation of the Nugent score was excellent (intraclass correlation-individual 0.93 (95 CI 0.92 to 0.94) and average 0.96 (95% CI 0.95 to 0.97)). The sensitivity of an elevated pH > 5 for a Nugent score > 7 was 21.9% while the specificity was 84.5%. The positive predictive value in our population was 33.7% with a negative predictive value of 75.0%. Conclusion. Though the Nugent score is internally accurate, the prediction of BV using vaginal pH alone has poor sensitivity and specificity.
Oral clindamycin between 13 and 20 weeks does not prevent preterm birth in women with a vaginal pH ≥5.0.
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