Data from: Ambulatory versus inpatient management of severe nausea and vomiting of pregnancy: a randomized control trial with patient preference arm

ABSTRACT
Objective
To determine whether ambulatory (outpatient, OP) treatment of severe nausea and vomiting of pregnancy (NVP) is as effective as inpatient (IP) care.
Design
Non-blinded randomized control trial (RCT) with patient preference arm
Setting
Multi-center
Participants
Women less than 20 weeks pregnant with severe NVP and associated ketonuria
Methods
Women participating in the RCT were randomized via web-based application to either ambulatory or IP treatment. Women declining randomisation entered the patient preference trial (PPT) arm. Protocols, data collection and follow-up were the same for all participants.
Main Outcome Measures
Primary outcome was reduction in Pregnancy Unique Quantification of Emesis (PUQE) score at 48 hours. Secondary outcomes were duration of treatment; improvement in symptom scores and ketonuria at 48 hours; re-attendances within 7 days of discharge; and comparison of symptoms at 7 days post discharge
Results
152/174 eligible women agreed to participate with 77/152 (51%) recruited to the RCT and 79/152 (49%) to the PPT.
Patients were initially compared in 4 groups (randomized IP, randomized OP, non-randomized IP and non-randomized OP). Comprehensive cohort analysis of participants in the (RCT) and (PPT) did not demonstrate any differences in patient demographics or baseline clinical characteristics. Pooled analysis of IP versus OP groups showed no difference in reduction in PUQE score at 48 hours (p=0.86). There was no difference in change in eating score (p=0.69), drinking score (p=0.77), wellbeing rating (p=0.64) or reduction in ketonuria (p=0.47) at 48 hours, with no difference in duration of index treatment episode (p=0.83) or re-attendances within 7 days (p=0.52).
Conclusions
Ambulatory management is an effective alternative to inpatient management of severe NVP. The trial also demonstrated that many women requiring treatment for HG have a strong preferences regarding treatment setting, which needs to be considered by care providers, especially given the psychological impact of HG.

摘要
研究目的
明确门诊治疗（ambulatory treatment, OP）与住院治疗（inpatient treatment, IP）对重度妊娠恶心呕吐（Nausea and Vomiting of Pregnancy, NVP）的疗效是否相当。

研究设计
非盲随机对照试验（randomized control trial, RCT），附带患者偏好队列。

研究场所
多中心。

研究对象
妊娠孕周小于20周、罹患重度妊娠恶心呕吐且合并酮尿症的女性。

研究方法
参与随机对照试验的女性通过网络应用程序随机分配至门诊治疗组或住院治疗组；拒绝随机分配的女性则纳入患者偏好试验（patient preference trial, PPT）队列。所有研究对象的研究方案、数据收集及随访流程均保持一致。

主要结局指标
主要结局为48小时时妊娠呕吐特异性量化评分（Pregnancy Unique Quantification of Emesis, PUQE）的降幅；次要结局包括治疗时长、48小时时症状评分及酮尿症的改善情况、出院后7天内的复诊率，以及出院后7天的症状对比情况。

研究结果
174名符合入组标准的女性中，152名同意参与研究，其中77名（51%）纳入随机对照试验，79名（49%）纳入患者偏好试验队列。
首先将研究对象分为4组进行初始比较：随机分配住院组、随机分配门诊组、非随机分配住院组、非随机分配门诊组。对随机对照试验及患者偏好试验队列的综合队列分析显示，研究对象的人口统计学特征及基线临床特征均无显著差异。将住院组与门诊组合并分析后发现，48小时时PUQE评分的降幅无显著差异（p=0.86）；48小时时进食评分（p=0.69）、饮水评分（p=0.77）、健康状况评分（p=0.64）的变化以及酮尿症的改善情况均无显著差异，且本次治疗疗程时长（p=0.83）及出院后7天内复诊率（p=0.52）也无显著差异。

研究结论
门诊管理可作为重度妊娠恶心呕吐住院管理的有效替代方案。本研究同时证实，许多需要接受妊娠剧吐（hyperemesis gravidarum, HG）治疗的女性对治疗场所存在强烈偏好，临床医护人员应予以充分考虑，尤其是考虑到妊娠剧吐带来的心理影响。