31: Preemptive Diclectin therapy for the management of nausea and vomiting of pregnancy and hyperemesis gravidarum


      Our primary objective in this study was to determine whether the initiation of pre-emptive use of Diclectin (delayed release combination of 10 mg pyridoxine and 10 mg doxylamine) before symptoms of nausea and vomiting of pregnancy (NVP) began can mitigate symptoms as compared to starting Diclectin only at first sign of NVP symptoms, in patients with a high risk for recurrence of severe NVP or hyperemesis gravidarum (HG).

      Study Design

      This study was a prospective, randomized controlled trial. Women with history of severe NVP and/or HG in their previous pregnancy were recruited to participate. Upon consent, patients were randomized to start taking Diclectin upon recognition of their pregnancy but before NVP symptoms began, or to start only upon appearance of symptoms. Both study groups received similar, intensive protocolized counseling as per evidence-based guidelines for NVP management.


      A total of 30 women were randomized to the preemptive study group and 29 to the control study group. There was a 43.3% reduction in the recurrence of HG with pre-emptive use of Diclectin as compared to only 20.6% reduction in the control group (p<0.05). There were 70% fewer cases of moderate-severe cases of NVP (PUQE ≥11) in the preemptive study group with Diclectin than in the control group (15.4% vs. 39.13%) in the first 3 weeks of NVP (p<0.04). Significantly more women in the preemptive group (78.2%) had their NVP resolved before delivery compared to the control group (50%) (p<0.002). The mean (SD) dose of Diclectin over the course of NVP was no different between the pre-emptive group 0.65 mg/kg/d (SD = 0.23) and the control group 0.56 mg/kg/d (0.24). Both study group patients received a mean of 8 follow-up calls (SD 1.8).


      Preemptive use of Diclectin combined with intensive protocolized counseling effectively decreases the risk of severe forms of NVP.