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临床试验/NCT06259747
NCT06259747已完成不适用

Potential Therapeutic Implications of Acutaping on Nausea and Vomiting During Pregnancy

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年2月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
pregnancy unique quantification of emesis and nausea questionnaire

研究概览

简要总结

This study will answer the following research question:

Is acutaping has therapeutic implications on symptoms of nausea and vomiting during pregnancy?

详细描述

Nausea and vomiting during pregnancy (NVP) are common symptoms, with prevalence rate from 50% to 90% . NVP symptoms often appear between weeks 5 and 6, peak at 8 to 9 weeks, and subside between weeks 16 and 20 .Long-term morning sickness during pregnancy increases the incidence of postpartum depression symptoms in women and severe NVP increases the chance of low birth weight .

NVP is multifactorial and the most common causes potentially including hormone imbalances, placental disorders, and genetic causes . Genetic factors, Evidence in support of a genetic predisposition to nausea and vomiting of pregnancy includes the following: (a) the concordance in frequency of nausea and vomiting of pregnancy in monozygotic twins ; (b) the finding that siblings and mothers of patients affected with nausea and vomiting of pregnancy are more likely to be affected than relatives of unaffected individuals ; (c) the variation in frequency between ethnic groups; (d) the higher frequency of nausea and vomiting of pregnancy in patients with predisposing conditions that are genetically determined such as taste sensation; and (e) the occurrence of nausea and vomiting of pregnancy in women with inherited glycoprotein hormone receptor defects.

The fundamental stimulus-a placental product, the triggering factor for nausea and vomiting of pregnancy has not been identified, although human chorionic gonadotropin and estrogens have been implicated. The principle reason for considering human chorionic gonadotropin initially was the close temporal association between peak human chorionic gonadotropin concentrations and peak nausea and vomiting of pregnancy symptoms. Conditions associated with higher human chorionic gonadotropin production are associated with nausea and vomiting of pregnancy. These include multiple gestation with hyperemesis gravidarum 4 to 5 times more common than in singletons .

Whatever the specific trigger, the emetic response is fundamentally the same: there is a marked reduction in gastric tone and motility followed by a retrograde giant contraction moving small intestinal contents into the stomach. Thereafter, contractions of the diaphragm and abdominal muscles combine with relaxation of the gastroesophageal sphincter to facilitate passage of gastrointestinal contents .

Although there are several pharmacological treatments for NVP, many medical professionals and expectant mothers prefer non-pharmacological therapy over pharmacological ones because of worry for their impact on foetal outcomes .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman with nausea and vomiting during pregnancy Primigravida With age ranges from 20-35years Gestational age 7-16 weeks Body mass index (BMI) less than 30 kg/m2 Not hospitalized due to hyperemesis gravidarum

排除标准

  • Gastrointestinal disorder Diabetes Dehydration

研究组 & 干预措施

acutaping and traditional medical treatment

Experimental

received acutaping in addition to traditional medical treatment (Doxylamine and Pyridoxine)

干预措施: Acutaping (Other)

acutaping and traditional medical treatment

Experimental

received acutaping in addition to traditional medical treatment (Doxylamine and Pyridoxine)

干预措施: Doxylamine and Pyridoxine (Drug)

traditional medical treatment only

Experimental

received traditional medical treatment only (Doxylamine and Pyridoxine

干预措施: Doxylamine and Pyridoxine (Drug)

结局指标

主要结局

pregnancy unique quantification of emesis and nausea questionnaire

时间窗: Measured before treatment , after first treatment (at 4th day) and after second treatment (at 8th day )

Quality of life in those pregnant women Score the quality of life question is on a scale of 0-10 with: 0(worst possible), 10 (as good as you felt before pregnancy).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mennat Allah Hassan Mohamed Elghoul

Demonstrator at women's health department

Kafrelsheikh University

研究点 (1)

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