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The Role of Zamzam Water in Idiopathic Oligohydramnios

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04684680
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Study Description
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Brief Summary:
The aim of this study is to evaluate the efficacy of drinking zamzam water versus tap water in increasing the AF index in women with oligohydramnios.

Condition or disease Intervention/treatment Phase
Oligohydramnios Dietary Supplement: zamzam water Dietary Supplement: tap water Not Applicable

Detailed Description:
Oligohydramnios refers to decrease in amniotic fluid and it is defined as a deepest fluid pocket of less than 2 cm or an amniotic fluid index of 5 cm or less. Oligohydramnios complicates 0.5% to 8% of pregnancies, and 12 % if postdates When it occurs in first half of pregnancy it is associated with birth defects while in second half it causes poor fetal growth, malpresentations , FHR decelerations , MAS , Fetal suicidal syndrome and increases cesarean section and management and prognosis depend on gestational age
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open label randomized controlled trial
Masking: None (Open Label)
Masking Description: open label randomized controlled trial
Primary Purpose: Treatment
Official Title: Effect of Zamzam Water on Amniotic Fluid Index, in Oligohydramnios : a Randomized Controlled Trial
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arms and Interventions
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Arm Intervention/treatment
Experimental: zamzam water
patient will receive the normal need of daily requirement of water (2.5 liter) in form of zamzam water till patients deliver or till term
 Dietary Supplement: zamzam water
will receive the normal need of daily requirement of water (2.5 liter) in form of zamzam water till patients deliver or till term
Other Name: study group
Active Comparator: tap water
will receive the normal need of daily requirement of water (2.5 liter) in form of tap water
 Dietary Supplement: tap water
will receive the normal need of daily requirement of water (2.5 liter) in form of tap water
Other Name: Active Comparator


Outcome Measures
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Primary Outcome Measures :
  1. amniotic fluid index [ Time Frame: 10 weeks ]
    the change of the amniotic fluid volume


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant female with idiopathic oligohydramnios
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant female with idiopathic oligohydramnios

Exclusion Criteria:

  • patients with medical disorder
  • congenital anomalies
  • premature rupture of membrane
  • Patient refuse to participate
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684680


Contacts
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Contact: Hany f Sallam, md +201022336052 ext 002 hanygyne@yahoo.com
Contact: nahla w shady, md +201022336052 ext 002 nahlagyn@yahoo.com

Locations
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Egypt
Aswan University Hospital Recruiting
Aswan, Egypt, 81528
Contact: Hany F Sallam, MD    0122336052 ext 002    hany.farouk@aswu.edu.eg   
Contact: Nahla W Shady, MD    01092440504 ext 002    nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Study Chair: nahla w shady, md Aswan universirty
More Information
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Responsible Party: hany farouk, A Professor, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT04684680    
Other Study ID Numbers: aswu/3oo/6/19
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Oligohydramnios
Pregnancy Complications