Investigating the effect of quince sauce in preventing nausea and vomiting of pregnancy
Design
This was a controlled, parallel-group, randomized, phase 2 clinical trial conducted on 80 women with normal pregnancies and mild to moderate nausea and vomiting. The random allocation method of the permutation blocks was using Random Allocation software.
Settings and conduct
This study was conducted on 80 women with normal pregnancies and mild to moderate nausea and vomiting referred to Hazrat Zainab Hospital in Shiraz. Women were randomly assigned to receive quince sauce and routine anti-nausea treatment. Blinding was not performed for pregnant women.
Participants/Inclusion and exclusion criteria
Being in a state of singleton and normal pregnancy
No molar pregnancy, twin pregnancy, and signs of threatened miscarriage,
No thyroid dysfunction or any known gastrointestinal disease
Mild to moderate nausea and vomiting symptoms
No use of any herbal or chemical anti-nausea or emetic medication in the past twenty-four hours
Intervention groups
Intervention group (A) included pregnant women who were treated with quince sauce 10 mg three times a day for 7 days.
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241105063604N1
Registration date:2024-11-15, 1403/08/25
Registration timing:prospective
Last update:2024-11-15, 1403/08/25
Update count:0
Registration date
2024-11-15, 1403/08/25
Registrant information
Name
Marzieh khezri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5884
Email address
mojtabaneydavoodi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of quince sauce in preventing nausea and vomiting of pregnancy
Public title
Investigating the effect of quince sauce in preventing nausea and vomiting of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being in a singleton, normal pregnancy where the gestational age is 6 to 22 weeks based on the first day of the last regular menstrual period or first trimester ultrasound.
Absence of molar pregnancy, twin pregnancy, and signs of threatened miscarriage
Absence of thyroid dysfunction and any known gastrointestinal disease
No known illness that causes nausea and vomiting
Mild to moderate nausea and vomiting
Not taking any herbal or chemical anti-nausea or anti-emetic medication within the past twenty-four hours.
No smoking
Exclusion criteria:
Severe nausea
Failure to take two or more courses of medication or concurrent use of other anti-nausea medications, such as herbal or chemical anti-nausea medications
Threatened miscarriage
Allergy to quince sauce and andasterone and vitamin B6
Age
From 18 years old to 35 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups (A and B). The random allocation method of permutation blocks will be performed using Random Allocation software. First, six different blocks will be created (ABBA, BABA, ABAB, BBAA, AABB and BABA) and one of these blocks will be randomly selected and, according to the order mentioned in the selected block, the patients will be divided into one of two groups (intervention) A or (control) B. Then, randomization will be performed for other patients as well. The intervention group (A) will include pregnant women who will be treated with quince sauce (made by the Faculty of Pharmacy, Shiraz University of Medical Sciences) for 7 days, 10 mg three times a day. The control group (B) will be prescribed the second drug andasterone and vitamin B6 for 1 tablet every 12 hours.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz, Zand Street, Central Building of University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-08-22, 1403/06/01
Ethics committee reference number
IR.SUMS.MED.REC.1403.369
Health conditions studied
1
Description of health condition studied
Nausea and vomiting of pregnancy
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
Nausea and vomiting of pregnancy
Timepoint
Before starting treatment and 7 days after starting treatment
Method of measurement
The second standard Rhodes Nausea and Vomiting Questionnaire was developed by Rhodes and McDaniel in 1999 and consists of 8 factors: the number, severity, and amount of vomiting, the number, duration, and severity of nausea, and the number and severity of retching, which are asked during the past 12 hours.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant women treated with quince sauce will receive 10 mg three times a day for 7 days.
Category
Treatment - Other
2
Description
Control group: Women treated with ondansetron and vitamin B6 for 1 tablet every 12 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zainab Hospital, Shiraz
Full name of responsible person
Marzieh Khezri
Street address
Holy Defense Intersection-Hazrat Zainab (PBUH) Educational and Therapeutic Center
City
Shiraz
Province
Fars
Postal code
7153813311
Phone
+98 71 3826 6811
Email
zeinabhp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Zand Street, Central Building of University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Khezri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street - Faculty of Medicine
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
dr.marziehkhezri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Khezri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street - Faculty of Medicine
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
dr.marziehkhezri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Khezri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street - Faculty of Medicine
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
dr.marziehkhezri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The publication of any matter related to the research project must be coordinated with the Vice President for Research of Shiraz University of Medical Sciences.