Pregnancy
Conditions
Keywords
Pregnancy, Dates, Vomiting, Haemoglobin, Morning Sickness of pregnancy, Hyperemesis gravidarum
Brief summary
The goal of this randomized clinical trial is to evaluate role of date fruit in alleviating morning sickness of pregnancy in pregnant females. The main question\[s\] it aims to answer \[is/are\]: The goal of this randomized clinical trial is to evaluate role of date fruit in The goal of this randomized clinical trial is to evaluate role of date fruit in alleviating vomiting due to morning sickness of pregnancy and in improving maternal hemoglobin in pregnant females. The main question\[s\] it aims to answer \[are\]: * Role of date fruit in alleviating severity and frequency of vomiting due to morning sickness of pregnancy in pregnant females. * Role of date fruit in improving haemoglobin levels in pregnant females. * To assess improvement of severity and frequency of vomiting due to morning sickness of pregnancy and improvement of hemoglobin levels in pregnant females, researchers will compare date fruit intake with antiemetic medication doxylamine succinate 10 mg + pyridoxine HCl 10 and diet only.
Detailed description
A randomized Controlled trial to assess benefits of date fruit in morning sickness of pregnancy symptoms, inclusive of nausea and vomiting and to improve haemoglobin levels in pregnant females.
Interventions
OTHERDate fruit
3 Dates after breakfast
DRUGDoxylamine succinate 10 mg + Pyridoxine HCl 10 mg
Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg , One per day
OTHERDiet
Avoidance of high in fat foods and enhanced intake of hydrating fruits and vegetables
Sponsors
Bahria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant females in 18 to 45 year old age group
Exclusion criteria
1. Females in 18 to 45 year old age group who are not pregnant. 2. Females less than 18 years old. 3. Females over 45 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 12 Weeks | Complete blood picture (Laboratory diagnostic tests) |
| Vomiting | 12 Weeks | PUQE-24 Score Unabbreviated scale title : The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24) Minimum Value : 4-6 (Mild) Maximum Value : ≥13 (Severe) Higher Scores mean worst outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue level | 12 weeks | FAS Unabbreviated scale title: Fatigue Assessment Scale (FAS) Minimum Value : Less less than 22 Maximum Value : 35 or more indicates severe fatigue Higher Scores mean worst outcome |
| Dietary Recall | 12 weeks | Direct compliance inquired via telephonic communication on regular basis |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORShehla M Baqai, MBBS, FCPS, FICS
Bahria University Health Sciences Campus Karachi
Outcome results
None listed