METHODS: Women at their first hospitalization for hyperemesis gravidarum were enrolled on admission to the ward and randomly assigned to receive either 5% dextrose-0.9% saline or 0.9% saline by intravenous infusion at a rate 125 mL/h over 24 hours in a double-blind trial. All participants also received thiamine and an antiemetic intravenously. Oral intake was allowed as tolerated. Primary outcomes were resolution of ketonuria and well-being (by 10-point visual numerical rating scale) at 24 hours. Nausea visual numerical rating scale scores were obtained every 8 hours for 24 hours.
RESULTS: Persistent ketonuria rates after the 24-hour study period were 10 of 101 (9.9%) compared with 11 of 101 (10.9%) (P>.99; relative risk 0.9, 95% confidence interval 0.4-2.2) and median (interquartile range) well-being scores at 24 hours were 9 (8-10) compared with 9 (8-9.5) (P=.73) in the 5% dextrose-0.9% saline and 0.9% saline arms, respectively. Repeated measures analysis of variance of the nausea visual numerical rating scale score as assessed every 8 hours during the 24-hour study period showed a significant difference in favor of the 5% dextrose-0.9% saline arm (P=.046) with the superiority apparent at 8 and 16 hours, but the advantage had dissipated by 24 hours. Secondary outcomes of vomiting, resolution of hyponatremia, hypochloremia and hypokalemia, length of hospitalization, duration of intravenous antiemetic, and rehydration were not different.
CONCLUSIONS: Intravenous rehydration with 5% dextrose-0.9% saline or 0.9% saline solution in women hospitalized for hyperemesis gravidarum produced similar outcomes.
CLINICAL TRIAL REGISTRATION: ISRCTN Register, www.controlled-trials.com/isrctn, ISRCTN65014409.
LEVEL OF EVIDENCE: I.
METHODS: Women at their first hospitalization for hyperemesis gravidarum were approached when intravenous antiemetic therapy was needed. They were randomly assigned to receive 25 mg promethazine or 10 mg metoclopramide every 8 hours for 24 hours in a double-blind study. Primary outcomes were vomiting episodes by diary and well-being visual numerical rating scale score (10-point scale) in the 24-hour main study period. Participants also filled out an adverse-effects questionnaire at 24 hours and a nausea visual numerical rating scale score at recruitment and at 8, 16, and 24 hours.
RESULTS: A total of 73 and 76 women, randomized to metoclopramide and promethazine, respectively, were analyzed. Median vomiting episodes were one (range 0-26) compared with two (range 0-26) (P=.81), and well-being visual numerical rating scale scores were 8 (range 1-10) compared with 7 (range 2-10) (P=.24) for metoclopramide and promethazine, respectively. Repeat-measures analysis of variance of the nausea visual numerical rating scale scores showed no significant difference between study drugs (F score=0.842, P=.47). Reported drowsiness (58.6% compared with 83.6%, P=.001, number needed to treat to benefit [NNTb] 5), dizziness (34.3% compared with 71.2%, Pgravidarum. The adverse effects profile was better with metoclopramide.