Ottawa Nutritional Guidelines for Nausea and Vomiting

Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)

Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)

Study Overview

• Status: Completed
• Conditions: Nausea Gravidarum
• Intervention / Treatment: Behavioral: Acupressure and nutritional advices

Detailed Description

Studying the Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial) using no pharmacological agents and life style modification in addition to acupressure to treat nausea and vomiting of pregnancy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. primigravida
2. gestational age of 7-13 weeks
3. singleton pregnancy
4. having a score of 7-12 on the (PUQE 24)
5. can read and write
6. having phone number
7. not receiving medications for reducing NVP, except for vitamin B6
8. wanted pregnancy.

Exclusion Criteria:

1. subject's unwillingness to continue the study
2. occurrence of obstetric complications during the study
3. hyper-emesis gravidarum
4. having physical or mental disorders
5. having oral/speech impairments
6. having assisted reproductive techniques for the present pregnancy
7. having two consecutive miscarriages before the current pregnancy
8. old primigravida
9. narcotic use or alcohol drinking
10. and subjects who will show signs and symptoms of hyperemesis gravidarum during the study will be dropped out and referred to medical care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine antenatal care; the control group will receive routine antenatal care and will not receive the guidelines group included 30 cases
Experimental: Ottawa guidelines; study group will receive routine antenatal care in addition to the Ottawa nutritional guidelines group included 30 cases	Behavioral: Acupressure and nutritional advices; Teaching using booklets and application of acupressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
control nausea and vomiting	control the frequency and severity of nausea and vomiting and measure it by using Pregnancy Unique Quantification of Emesis	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maintain normal body weight and prevent hospitalization	Monitor mother weight by calipered weight scale to monitor weight loss related to nausea and vomiting	3 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Noura Mo Eltoukhi, PhD, Cairo university; Principal Investigator: Noura M Eltoukhi, lecturer, Faculty of Nursing Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: IORG0003381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with researchers upon reasonable request following publication of the main results."
• IPD Sharing Time Frame: "IPD will be available starting after publication and will remain available
• IPD Sharing Access Criteria: Access to the de-identified individual participant data will be granted to qualified researchers with a methodologically sound proposal. Requests should be submitted to the study sponsor or principal investigator and will be reviewed by a data access committee
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No