An interventional study of Antiemetic Drug and Vitamin B6 in Emesis Pregnancy, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
This study will be conducted to investigate the effect of kinesiotaping on emesis in pregnant women.
Emesis gravidarum (EG) is a common condition among pregnant women, with a prevalence of 12.5% worldwide. It has a significant impact on the body where the mother becomes very weak, the face is pale and the frequency of urination decreases drastically so, the body fluids are reduced, and blood becomes thick (hem concentration). This condition can slow down blood circulation so that oxygen and food supply to the tissues are also reduced which can cause tissue damage and endangers the health of the mother and her fetus. Also, EG known to reduce a woman's quality of life (QOL). It was reported that 80% of women with emesis have reduced QOL.
Women with EG fear from the use of the antiemetic drugs and the possible side effects such as drowsiness, sedation, arrhythmia, poor efficacy of pharmacological approach in the past leads to difficulty in the treatment of nausea and vomiting during pregnancy. Non- pharmacological option has been proposed to be effective in the treatment of EG and hyperemesis gravidarum. Such as hypnosis, acustimulation, tactile massage, psychotherapy, acupuncture and kinesiotape.
Kinesiotape is a drug-free and an elastic therapeutic tape used for treating various musculoskeletal problems such as injury, pain, and dysfunction and a variety of other disorders. The kinesiotaping was found to be effective in stimulation of large and small intestinal peristalsis.
Due to lack of previous studies that examined the effect of kinesiotape on EG. This raises the need of further studies in this issue which will give an insight about the efficacy of kinesiotape as a safe, non-invasive and inexpensive method used to alleviate nausea and vomiting during pregnancy. This will be of valuable benefits in medical service organization and increase body of knowledge of physical therapists in scientific field.
1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.
This study's planned enrollment of 50 is below the median of 107 across 935 interventional studies indexed under Vomiting.
Browse Vomiting studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
It will be consisted of 25 pregnant women who will receive kinesiotaping (I band) for 5 days in addition to antiemetic drugs (ondansetron 4 mg, every 12 hours), vitamin B6 (50 mg, once daily), and home care advice.
Drug: Antiemetic Drug · Dietary Supplement: Vitamin B6 · Other: Home care advice · Other: Kinesiotaping
It will be consisted of 25 pregnant women who will receive antiemetic drugs (ondansetron 4mg every 12 hours, vitamin B6 (50 mg, once daily), and home care advice only for 5 days.
Drug: Antiemetic Drug · Dietary Supplement: Vitamin B6 · Other: Home care advice
All participants in the two groups will receive antiemetic drugs (ondansetron 4 mg) every 12 hours, for 5 days.
Also known as: Ondansetron 4 mg
All participants in the two groups will receive vitamin B6 (50 mg), once daily, for 5 days.
All participants in both groups will be advised to eat small portions of food, drink plenty of liquids, and avoid fatty and fried foods. Additionally, they should steer clear of highly spiced foods, foods and beverages with strong odors, caffeine, and consume neither very hot nor very cold foods and liquids.
It will be applied for all participants in the experimental group only for 5 days. The participant will be asked to stand in erect position, her hands beside her body then applying the kinesiotape from origin (from top to bottom where the stomach is placed on the abdominal region) to insertion (alongside the gastric curvature) with tension 25% for 5 days.
Visual analogue scale (VAS)
It will be used for all participants in both groups pre and post-treatment to assess the severity of symptoms of emesis gravidarum. Patients will be asked on their first visit to grade the severity of their nausea over the past 24 hours (baseline scores) by marking an "X" corresponding to their perceived states on a 10-cm horizontal line, ranging from 0 no nausea to 10 nausea as bad as it could be. On the following 2 weeks of treatment, recordings of the severity of nausea will be made twice daily at noon and at bedtime.
Time frame: 24 hours
Rhodes index
It will be used for all participants in both groups pre and post-treatment to assess severity of nausea and vomiting for all participants in both groups before and after the study. Each woman will be asked to self-report questions such as length and episodes of nausea, number of vomits, number of retches, and volume of vomits on the 5-point scale with 1 indicating minimal or no symptom and 5 representing the worst symptom.
Time frame: 24 hours
Pregnancy unique quantification of emesis (PUQE)
It will be used for all participants in both groups pre and post-treatment to assess the symptoms of emesis gravidarum. This questionnaire contains three questions regarding the time-span of nausea, vomiting and retching respectively, as well as one question assessing the global psychological and physical quality of life (QOL). Each woman will be asked to choose the answer that suit the best of her situation for the last 24 hours. The PUQE score is calculated by adding the values from each category, and can range from a minimum of 1 to a maximum of 15, with higher scores indicating worse outcome.
Time frame: 24 hours
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cairo University