PolyhydramniosNCT07067593
Amnioreduction in Polyhydramnios
An observational study of Polyhydramnios, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this work is to review the indications, procedural complications and outcomes of amnioreduction in pregnancies complicated by polyhydramnios. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Polyhydramnios
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All pregnant women between 24 to 38 weeks attending Fetal Medicine Unit at Women's health hospital for antenatal care or admitted due to antepartum hemorrhage or for scheduled surgery and meeting the inclusion criteria are counseled to participate in our study after informed consent. sample size will be devided into 2 groups: Group 1 : patients with Amnioreduction Group 2 : patients with conservative management (without amnioreduction)
Who may be able to join
- Pregnant women 20- 38 weeks
- Patients with polyhydramnios
Who cannot join
- Lethal fetal anomalies
- Pre labor rupture of membranes
- Placental separation
- Chorioamnionitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Women's Health Hospital
Asyut
Mohamed Fekry, 0882312388, mohamedbeethoven2040@gmail.com
Mohamed Fekry, PhD
About this study
Official title: Benefits and Risks of Amnioreduction for Management of Pregnant Women With Polyhydramnios
The aim of this work is to review the indications, procedural complications and outcomes of amnioreduction in pregnancies complicated by polyhydramnios.
Read the detailed description
Polyhydramnios is the presence of excessive amniotic fluid in the amniotic sac and it's prevalence reaches 2% of all pregnancies . Polyhydramnios is diagnosed based on ultrasound criteria, as an amniotic fluid index (AFI) >25 cm or maximal vertical pocket > 8 cm . There is a recognized association of polyhydramnios and adverse pregnancy outcomes, including perinatal death, fetal abnormality and preterm birth . Management of the pregnancy can be problematic, particularly in severe cases, due to issues surrounding maternal discomfort and the risk of preterm birth. Amnioreduction, widely used in the management of polyhydramnios, is an option available to palliate maternal symptomatology and potentially prolong the pregnancy . Previous publications have shown a reduction in the risk for premature rupture of membranes and preterm labor decrease, placental perfusion improvement, and relief of maternal discomfort following amnioreduction
- Conditions
- Polyhydramnios
- Keywords
- Amnioreduction, Polyhydramnios
- Medical subject headings
- Polyhydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Amnioreduction | Not described | |
| Conservative | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at delivery
Determine Gestational age at delivery in polyhydramnios patients . Increased age is good.
Measured: 4 months
Rate of PROM
Number of cases developed PROM
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyhydramniosStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal M.fekry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067593
- Sponsor's protocol ID
- AMN
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits and Risks of Amnioreduction for Management of Pregnant Women With Polyhydramnios
- ClinicalTrials.gov ID
- NCT07067593
- Acronym / sponsor ID
- AMN
- Conditions
- Polyhydramnios
- Keywords
- Amnioreduction, Polyhydramnios
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 16 Jul 2025 (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 work is to review the indications, procedural complications and outcomes of amnioreduction in pregnancies complicated by polyhydramnios.
Detailed description
Polyhydramnios is the presence of excessive amniotic fluid in the amniotic sac and it's prevalence reaches 2% of all pregnancies . Polyhydramnios is diagnosed based on ultrasound criteria, as an amniotic fluid index (AFI) >25 cm or maximal vertical pocket > 8 cm . There is a recognized association of polyhydramnios and adverse pregnancy outcomes, including perinatal death, fetal abnormality and preterm birth . Management of the pregnancy can be problematic, particularly in severe cases, due to issues surrounding maternal discomfort and the risk of preterm birth. Amnioreduction, widely used in the management of polyhydramnios, is an option available to palliate maternal symptomatology and potentially prolong the pregnancy . Previous publications have shown a reduction in the risk for premature rupture of membranes and preterm labor decrease, placental perfusion improvement, and relief of maternal discomfort following amnioreduction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amnioreduction | – | – |
| Conservative | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All pregnant women between 24 to 38 weeks attending Fetal Medicine Unit at Women's health hospital for antenatal care or admitted due to antepartum hemorrhage or for scheduled surgery and meeting the inclusion criteria are counseled to participate in our study after informed consent. sample size will be devided into 2 groups: Group 1 : patients with Amnioreduction Group 2 : patients with conservative management (without amnioreduction)
Key inclusion criteria (2 listed)
- Pregnant women 20- 38 weeks
- Patients with polyhydramnios
Key exclusion criteria (4 listed)
- Lethal fetal anomalies
- Pre labor rupture of membranes
- Placental separation
- Chorioamnionitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gestational age at delivery
Time frame: 4 months
Determine Gestational age at delivery in polyhydramnios patients . Increased age is good.
Rate of PROM
Time frame: 4 months
Number of cases developed PROM
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
Related trials for Polyhydramnios
Recruiting
"Fetal gRowth AbnorMality dEtection Trial"
Small for Gestational Age Infant, Large for Gestational Age Infant
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyhydramnios, run by Assiut University 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 2 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: opening soon, as of the sponsor's last update on 16 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Fekry, PhD (0882312388, mohamedbeethoven2040@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age at delivery (time frame: 4 months). The study lists 2 primary outcomes in all. 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 16 Jul 2025.