In a study to be presented on February 14 between 1:15 p.m., and 3:30 p.m. PST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting ™, in San Francisco, California, researchers will present data showing the effectiveness of preemptive treatment for hyperemesis gravidarum and severe morning sickness.

Hyperemesis gravidarum is a severe form of morning sickness which affects two percent of pregnant women. HG is marked by persistent nausea and vomiting, and can begin early in the first trimester, continuing well into the second, third or even up to giving birth. Women who suffer from HG become severely dehydrated, and often end up in the hospital on IV fluids. Recurrence rate for women who had HG in their first pregnancy is 75-85 percent in subsequent pregnancies, and the condition can be fatal.

Previous treatment for HG was to administer medication (Diclectin in Canada, Bendectin in the US) at the onset of symptoms, but this course of treatment provided little, if any, relief.

Drs. Gideon Koren and Caroline Maltepe, of The Hospital for Sick Children in Toronto, ON, Canada, divided 59 women with a history of HG or severe morning sickness into two groups: one would begin taking Diclectin as soon as the pregnancy was discovered; the second group would begin treatment at the first sign of nausea.

They found the group receiving treatment before the onset of symptoms, had a significant decrease in risk of severe nausea and vomiting.

“This is the first time there is an answer,” said Dr. Koren. “Women who have experienced hyperemesis are so traumatized by it, they are afraid of a second pregnancy.”

Dr. Koren, who with Dr. Maltepe runs a severe morning sickness counseling program at The Hospital for Sick Children, says the drug used to treat HG is safe to take throughout pregnancy or even before conception.

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Koren and Maltepe conducted the study at The Hospital for Sick Children, The Motherisk Program/Division of Clinical Pharmacology and Toxicology, Toronto, ON, Canada.

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine. The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed.

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

Gideon Koren1, Caroline Maltepe1

1The Hospital for Sick Children, The Motherisk Program/Division of Clinical Pharmacology and Toxicology, Toronto, ON, Canada

OBJECTIVE: 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.

RESULTS: 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).

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

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Vicki Bendure
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202-374-9259
Society for Maternal-Fetal Medicine