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Ottawa Nutritional Guidelines for Nausea and Vomiting

Primary Purpose

Nausea Gravidarum

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Acupressure and nutritional advices
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea Gravidarum

Eligibility Criteria

22 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine antenatal care

Ottawa guidelines

Arm Description

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

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

Outcomes

Primary Outcome Measures

control nausea and vomiting
control the frequency and severity of nausea and vomiting and measure it by using Pregnancy Unique Quantification of Emesis

Secondary Outcome Measures

maintain normal body weight and prevent hospitalization
Monitor mother weight by calipered weight scale to monitor weight loss related to nausea and vomiting

Full Information

First Posted
March 30, 2022
Last Updated
May 6, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05370170
Brief Title
Ottawa Nutritional Guidelines for Nausea and Vomiting
Official Title
Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea Gravidarum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine antenatal care
Arm Type
No Intervention
Arm Description
the control group will receive routine antenatal care and will not receive the guidelines group included 30 cases
Arm Title
Ottawa guidelines
Arm Type
Experimental
Arm Description
study group will receive routine antenatal care in addition to the Ottawa nutritional guidelines group included 30 cases
Intervention Type
Behavioral
Intervention Name(s)
Acupressure and nutritional advices
Intervention Description
Teaching using booklets and application of acupressure
Primary Outcome Measure Information:
Title
control nausea and vomiting
Description
control the frequency and severity of nausea and vomiting and measure it by using Pregnancy Unique Quantification of Emesis
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
maintain normal body weight and prevent hospitalization
Description
Monitor mother weight by calipered weight scale to monitor weight loss related to nausea and vomiting
Time Frame
3 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Faculty of Nursing
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Ottawa Nutritional Guidelines for Nausea and Vomiting

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