NCT04684680

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

September 5, 2020

Last Update Submit

August 6, 2021

Conditions

Oligohydramnios

Outcome Measures

Primary Outcomes (1)

  • amniotic fluid index

    the change of the amniotic fluid volume

    10 weeks

Study Arms (2)

zamzam water

EXPERIMENTAL

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

tap water

ACTIVE COMPARATOR

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

Dietary Supplement: tap water

Interventions

zamzam waterDIETARY_SUPPLEMENT

will receive the normal need of daily requirement of water (2.5 liter) in form of zamzam water till patients deliver or till term

Also known as: study group
zamzam water
tap waterDIETARY_SUPPLEMENT

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

Also known as: Active Comparator
tap water

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant female with idiopathic oligohydramnios
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant female with idiopathic oligohydramnios

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Oligohydramnios

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • nahla w shady, md

    Aswan universirty

    STUDY CHAIR

Central Study Contacts

Hany f Sallam, md

CONTACT

+201022336052hanygyne@yahoo.com

nahla w shady, md

CONTACT

+201022336052nahlagyn@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
open label randomized controlled trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: open label randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A Professor

Study Record Dates

First Submitted

September 5, 2020

First Posted

December 24, 2020

Study Start

January 1, 2021

Primary Completion

September 30, 2021

Study Completion

November 1, 2021

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)