Methods
hyperemesis gravidarum, nausea, vomiting of pregnancy, dehydration, Emesis
PCT, RECRUITMENT, VOMITING OF PREGNANCY, DEHYDRATION, SECONDARY
This is a randomized controlled trial comparing watermelon and dietary advice leaflet to dietary advice leaflet only (control) at hospital discharge for HG. The trial was approved by our center’s Medical Ethics Committee (approval on 21/05/2019; reference number 2019327–7262) and registered in the International Standard Randomized Controlled Trials Number registry on 24/05/2019; reference number ISRCTN96125404 (Our HG cases were characterized ‘intractable nausea and vomiting of pregnancy with dehydration and starvation clinically judged to require hospitalization for intravenous rehydration and antiemetic drug administration’ [Women were assessed for eligibility by scrutinizing their medical records during their inpatient management of HG in the gynecology ward, University Malaya Medical Center, Kuala Lumpur, Malaysia usually on the day of discharge. Inclusion criteria were a diagnosis of HG, gestation age less than 16 weeks [Pregnancy-Unique Quantification of Emesis (PUQE-24) score [We avoided the mention of watermelon as much as possible during the recruitment process to minimize confounding arising from women in the control arm being motivated to consume watermelon. The study title in the Patient Information Sheet was “The effect of standard dietary advice in hyperemesis gravidarum patients: a prospective trial”; this approach was approved by the Ethics board.The randomization sequence was generated in random blocks of 4 or 8 using random number generator at random.org by investigator (co-author PCT) who was not involved in enrolment. Numbered sealed opaque envelopes were prepared. The lowest numbered envelope available was assigned to the newest recruit. Randomization was by opening the sealed envelope just prior to discharge.Participants randomized to watermelon and dietary advice leaflet were supplied with two fresh red-fleshed watermelon (approximately 4 kg weight) to take home (Supplementary material SIdentical, commercially procured ordinary electronic weighing scales (providing weight measure in 0.1 kg increments) were provided free of charge to every participant for their exclusive use within the trial. The participants used their allocated personal weighing scale for the predischarge, week 1 and week 2 weighings. A written standard operating procedure provided instructions on the timing, clothing worn and bladder emptying requirements for the weighing (Supplementary material SParticipants were not blinded to their allocated intervention as the nature of the interventions were obvious. However, the mention of watermelon was avoided prior to randomization and subsequently in interaction with the controls.Primary outcomes were change in bodyweight in 1st week and through into the 2nd week after hospital discharge compared to bodyweight at discharge, evaluated across trial arms. Main secondary outcomes were HG symptoms assessed with PUQE-24 [For sample size calculation, we postulate a 0.5 kg difference in weight change by the end of week 1 across trial arms with a standard deviation (SD) of 1 kg in the weight change distribution for both arms. Applying α of 0.05, power of 80%, and 1 to 1 randomization ratio using Student t-test for analysis, 64 participants are required in each arm (Data were entered into SPSS (Version 23, IBM, SPSS Statistics). The 1-sample Kolmogorov–Smirnov test was used to check for normal distribution of continuous data. Data were expressed as numbers (%), mean ± standard deviation (normally distributed continuous data) or median [interquartile range IQR] (ordinal or non-normally distributed continuous data). The t test was used to compare means where data is normally distributed and the Mann–Whitney U test applied to non-normally distributed or ordinal data. Nominal data sets were analyzed with the Chi-square test. Two-sided P values were reported. 