Preemptive Treatment of Nausea and Vomiting of Pregnancy: Results of a Randomized Controlled Trial

Abstract

Objectives. To determine whether the initiation of treatment (preemptive treatment) before the symptoms of nausea and vomiting of pregnancy (NVP) versus when the symptoms begin can improve the outcome in patients at a high risk for recurrence of severe NVP. Study Design. Prospective, randomized controlled trial. Results. Preemptive therapy conferred a significant reduction in HG as compared to the previous pregnancy (P = 0.047). In the preemptive arm, there were 2.5-fold fewer cases of moderate-severe cases of NVP than those in the control group (15.4% versus 39.13%) in the first 3 weeks of NVP (P = 0.05). In the preemptive group, significantly more women had their NVP resolved before giving birth (78.2% versus 50%) (P < 0.002). Conclusions. Preemptive treatment with antiemetics is superior to the treatment that starts only when the symptoms have already occurred in decreasing the risk of severe forms of NVP.

Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment

“…l The evidence available for pyridoxine/doxylamine combinations is varied, but two trials appeared to be at low risk of bias 84,117 with the other two having an unclear risk of bias profile. 65,95 l The quality of the evidence is low and was downgraded due to clinical heterogeneity and sparseness of data in most comparisons.…”

“…The trial of Maltepe and Koren 117 did not report either pregnancy outcomes or adverse events. UKTIS data on doxylamine/pyridoxine combination treatment are provided in Appendix 7.…”

“…68,71,90 Diclectin (a vitamin B6 and antihistamine combination), which is not currently available within the UK, also appears to be more effective than placebo. 65,84,117 Further, pre-emptive treatment with Diclectin before symptoms of NVP begin in women at high risk of severe NVP recurrence appears to result in a reduced risk of moderate/severe NVP compared with women who take Diclectin once symptoms begin. 117 Dopamine antagonists were used in one trial which was judged to be at low risk of bias 106 and one poor-quality non-randomised study.…”

“…Of the included RCT studies, 32 were judged to have low risk of bias in relation to the blinding of participants and other personnel involved in the trial, 41,57,[59][60][61][62][63][64]67,71,72,74,79,[81][82][83][84][85]90,93,99,100,102,103,105,106,108,110,112,113,116,117 generally through the provision of medication in identical formats for both active and placebo. Sixteen studies were judged to have high risk of bias in this respect, for example due to clear differences in either the appearance, dosage rates or mode of delivery between intervention and placebo comparator, or as a result of evidence that the research staff involved were aware of allocation status.…”

“…These nodes and lines, however, do not represent the weight of evidence in the review as this would also be influenced by sample size and the precision of estimates, as well as other factors. The plot did not include a trial on pre-emptive treatment of doxylamine/pyridoxine combination, outpatient versus inpatient care 117,127 or two four-arm trials, 68,101 which would have over-reported the number of comparisons in the network plot. These interventions included dietary instructions only, or together with either placebo, antihistamines or antihistamine/vitamin B6 combination in one trial 68 and traditional acupuncture, P6 acupuncture, placebo or no acupuncture in another trial.…”