Ottawa Nutritional Guidelines for Nausea and Vomiting

NCT05370170 | Completed

• 1 other identifier: IORG0003381
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nausea Gravidarum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• maintain normal body weight and prevent hospitalization

  3 weeks

Study Arms (2)

Routine antenatal care

NO INTERVENTION

the control group will receive routine antenatal care and will not receive the guidelines group included 30 cases

Ottawa guidelines

EXPERIMENTAL

study group will receive routine antenatal care in addition to the Ottawa nutritional guidelines group included 30 cases

Behavioral: Acupressure and nutritional advices

Interventions

Acupressure and nutritional advices BEHAVIORAL

Teaching using booklets and application of acupressure

Ottawa guidelines

Eligibility Criteria

• Age: 22 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Nursing

Cairo, Egypt

Location

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Noura Mo Eltoukhi, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Noura M Eltoukhi, lecturer

  Faculty of Nursing Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: May 11, 2022
• Study Start: January 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: "IPD will be available starting after publication and will remain available
• 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

Locations

EG (1)