Ottawa Nutritional Guidelines for Nausea and Vomiting

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05370170
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.9
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nausea Gravidarum	Behavioral: Acupressure and nutritional advices	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. control nausea and vomiting [3 weeks]

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

Secondary Outcome Measures

1. maintain normal body weight and prevent hospitalization [3 weeks]

   Monitor mother weight by calipered weight scale to monitor weight loss related to nausea and vomiting

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Nursing	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Noura Mohamed Eltoukhy, Assistant lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT05370170
• Other Study ID Numbers: IORG0003381
• First Posted: May 11, 2022
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nausea; Vomiting

Study Results

No Results Posted as of May 11, 2022