OligohydramniosNCT04684680
The Role of Zamzam Water in Idiopathic Oligohydramnios
A study testing zamzam water and tap water in people with Oligohydramnios, run by Aswan University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Oligohydramnios
- What is being tested?
- zamzam water and tap water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant female with idiopathic oligohydramnios
Who cannot join
- patients with medical disorder
- congenital anomalies
- premature rupture of membrane
- Patient refuse to participate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University Hospital
Aswān, 81528
Hany F Sallam, MD, 0122336052 ext. 002, hany.farouk@aswu.edu.eg
Nahla W Shady, MD, 01092440504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: 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.
Read the 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
- Conditions
- Oligohydramnios
- Being tested
- zamzam water, tap water
- Medical subject headings
- Oligohydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zamzam waterDietary supplement
Also called study group
will receive the normal need of daily requirement of water (2.5 liter) in form of zamzam water till patients deliver or till term
tap waterDietary supplement
Also called Active Comparator
will receive the normal need of daily requirement of water (2.5 liter) in form of tap water
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: tap water |
What is being measured
The primary outcome is the main question the study is designed to answer.
amniotic fluid index
the change of the amniotic fluid volume
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Jan 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligohydramniosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- nahla w shady, md, Study chair, Aswan universirty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684680
- Sponsor's protocol ID
- aswu/3oo/6/19
- Status last verified
- Aug 2021
- First submitted
- 5 Sep 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zamzam Water on Amniotic Fluid Index, in Oligohydramnios : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04684680
- Acronym / sponsor ID
- aswu/3oo/6/19
- Conditions
- Oligohydramnios
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| zamzam water | Experimental | Dietary Supplement: zamzam waterpatient will receive the normal need of daily requirement of water (2.5 liter) in form of zamzam water till patients deliver or till term |
| tap water | Active comparator | Dietary Supplement: tap waterwill receive the normal need of daily requirement of water (2.5 liter) in form of tap water |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant female with idiopathic oligohydramnios
Key exclusion criteria (4 listed)
- patients with medical disorder
- congenital anomalies
- premature rupture of membrane
- Patient refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zamzam waterAlso: study groupwill 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 waterAlso: Active Comparatorwill receive the normal need of daily requirement of water (2.5 liter) in form of tap water | Dietary supplement | tap water |
Primary outcome
amniotic fluid index
Time frame: 10 weeks
the change of the amniotic fluid volume
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nahla w shady, md study chair
Aswan universirty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zamzam water and tap water in people with Oligohydramnios, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hany f Sallam, md (+201022336052 ext. 002, hanygyne@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amniotic fluid index (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.