The Role of Zamzam Water in Idiopathic Oligohydramnios

Effect of Zamzam Water on Amniotic Fluid Index, in Oligohydramnios : a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Oligohydramnios
• Intervention / Treatment: Dietary supplement: zamzam water; Dietary supplement: tap water

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hany f Sallam, md; Phone Number: 002 +201022336052; Email: hanygyne@yahoo.com
• Study Contact Backup: Name: nahla w shady, md; Phone Number: 002 +201022336052; Email: nahlagyn@yahoo.com

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnant female with idiopathic oligohydramnios

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amniotic fluid index	the change of the amniotic fluid volume	10 weeks

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: September 5, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Oligohydramnios
• Other Study ID Numbers: aswu/3oo/6/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No