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The Role of Zamzam Water in Idiopathic Oligohydramnios

Primary Purpose

Oligohydramnios

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
zamzam water
tap water
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oligohydramnios

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • pregnant female with idiopathic oligohydramnios

Exclusion Criteria:

  • patients with medical disorder
  • congenital anomalies
  • premature rupture of membrane
  • Patient refuse to participate

Sites / Locations

  • Aswan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

zamzam water

tap water

Arm Description

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

will receive the normal need of daily requirement of water (2.5 liter) in form of tap water

Outcomes

Primary Outcome Measures

amniotic fluid index
the change of the amniotic fluid volume

Secondary Outcome Measures

Full Information

First Posted
September 5, 2020
Last Updated
August 6, 2021
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04684680
Brief Title
The Role of Zamzam Water in Idiopathic Oligohydramnios
Official Title
Effect of Zamzam Water on Amniotic Fluid Index, in Oligohydramnios : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.
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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
open label randomized controlled trial
Masking
None (Open Label)
Masking Description
open label randomized controlled trial
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
zamzam water
Arm Type
Experimental
Arm Description
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
Arm Title
tap water
Arm Type
Active Comparator
Arm Description
will receive the normal need of daily requirement of water (2.5 liter) in form of tap water
Intervention Type
Dietary Supplement
Intervention Name(s)
zamzam water
Other Intervention Name(s)
study group
Intervention Description
will receive the normal need of daily requirement of water (2.5 liter) in form of zamzam water till patients deliver or till term
Intervention Type
Dietary Supplement
Intervention Name(s)
tap water
Other Intervention Name(s)
Active Comparator
Intervention Description
will receive the normal need of daily requirement of water (2.5 liter) in form of tap water
Primary Outcome Measure Information:
Title
amniotic fluid index
Description
the change of the amniotic fluid volume
Time Frame
10 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant female with idiopathic oligohydramnios
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pregnant female with idiopathic oligohydramnios Exclusion Criteria: patients with medical disorder congenital anomalies premature rupture of membrane Patient refuse to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany f Sallam, md
Phone
+201022336052
Ext
002
Email
hanygyne@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
nahla w shady, md
Phone
+201022336052
Ext
002
Email
nahlagyn@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nahla w shady, md
Organizational Affiliation
Aswan universirty
Official's Role
Study Chair
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany F Sallam, MD
Phone
0122336052
Ext
002
Email
hany.farouk@aswu.edu.eg
First Name & Middle Initial & Last Name & Degree
Nahla W Shady, MD
Phone
01092440504
Ext
002
Email
nahla.elsayed@aswu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Role of Zamzam Water in Idiopathic Oligohydramnios

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