Idiopathic Polyhydramios CasesNCT06211855
Cerebroplacental Ratio and Perinatal Outcomes in Mild and Moderate Idiopathic Polyhydramios Cases
An observational study of Idiopathic Polyhydramios Cases, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the predictability of fetal Doppler parameters in terms of perinatal adverse outcomes in singleton pregnancies with mild and moderate idiopathic polyhydramnios Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Polyhydramios Cases
- What is being tested?
- doppler assesment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Nov 2023
- How long will I take part?
- 9 Months
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women diagnosed with mild-moderate IP and randomly selected low-risk singleton pregnancies without polyhydramnios were included in the study one-on-one by matching their gestational ages.
Who may be able to join
- Pregnant women diagnosed with mild-moderate IP ,selected low-risk singleton pregnancies without polyhydramnios
Who cannot join
- Women who had chromosomal or anatomical abnormalities, multiple pregnancies, oligohydramnios (AFI 5 cm), severe polyhydramnios, fetal growth restriction, elective cesarean section (CS), pre-existing conditions (hypertension, diabetes, thrombophilia), or obstetric complications (gestational hypertension, preeclampsia, gestational diabetes) were excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Meram, Konya, 42140
About this study
This study aims to evaluate the predictability of fetal Doppler parameters in terms of perinatal adverse outcomes in singleton pregnancies with mild and moderate idiopathic polyhydramnios
Read the detailed description
Pregnant women diagnosed with mild-moderate IP and randomly selected low-risk singleton pregnancies without polyhydramnios were included in the study one-on-one by matching their gestational ages. The diagnosis of polyhydramnios was made if the AFI was 24 cm and above.
- Conditions
- Idiopathic Polyhydramios Cases
- Being tested
- doppler assesment
- Keywords
- polyhidramnios,cerebroplacental ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler assesmentDiagnostic test
In all cases, the measurement, including UA PI and MCA PI, was measured with a 6-4 MHz convex transabdominal probe. All measurements were made by an obstetrician (Ş.D.) with 28 years of experience. Doppler measurements were collected from the proximal third of the MCA and the free-floating segment of the umbilical cord, ensuring that the angle of insonation was as close to zero as feasible and that fetal movements were absent
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Polyhydramios Cases | The group with polyhydramnios was divided into two groups according to whether the CPR value was below 1.08 or 1.08 and above Receives: Diagnostic Test: doppler assesment | |
| low-risk pregnant women | The control group included low-risk pregnant women who did not have polyhydramnios. Women who had chromosomal or anatomical abnormalities, multiple pregnancies, oligohydramnios (AFI 5 cm), severe polyhydramnios, fetal growth restriction, elective cesarean section (CS), pre-existing conditions (hypertension, diabetes, thrombophilia), or obstetric complications (gestational hypertension, preeclampsia, gestational diabetes) were excluded. Receives: Diagnostic Test: doppler assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
perinatal outcome
adverse perinatal outcome: The week of birth and type of birth of all pregnant women participating in the study will be recorded. Premature birth rates and reasons for cesarean section will be questioned in all pregnant women. Birth weights of all neonates, 1st and 5th minute Apgar scores, and admissions to the neonatal intensive care unit will be recorded. Necessary statistical evaluation will be made in all healthy and polyhydramnios cases.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Jan 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Polyhydramios CasesStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, şükran doğru, Necmettin Erbakan University
- Investigators
- şükran doğru, Principal investigator, NECMETTİN ERBAKAN UNIVERCITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211855
- Sponsor's protocol ID
- 2023/4702 (17181
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: shared when the work is completed
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebroplacental Ratio and Perinatal Outcomes in Mild and Moderate Idiopathic Polyhydramios Cases
- ClinicalTrials.gov ID
- NCT06211855
- Acronym / sponsor ID
- 2023/4702 (17181
- Conditions
- Idiopathic Polyhydramios Cases
- Keywords
- polyhidramnios,cerebroplacental ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 18 Jan 2024 (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.
This study aims to evaluate the predictability of fetal Doppler parameters in terms of perinatal adverse outcomes in singleton pregnancies with mild and moderate idiopathic polyhydramnios
Detailed description
Pregnant women diagnosed with mild-moderate IP and randomly selected low-risk singleton pregnancies without polyhydramnios were included in the study one-on-one by matching their gestational ages. The diagnosis of polyhydramnios was made if the AFI was 24 cm and above.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Polyhydramios Cases | – | Diagnostic Test: doppler assesmentThe group with polyhydramnios was divided into two groups according to whether the CPR value was below 1.08 or 1.08 and above |
| low-risk pregnant women | – | Diagnostic Test: doppler assesmentThe control group included low-risk pregnant women who did not have polyhydramnios. Women who had chromosomal or anatomical abnormalities, multiple pregnancies, oligohydramnios (AFI 5 cm), severe polyhydramnios, fetal growth restriction, elective cesarean section (CS), pre-existing conditions (hypertension, diabetes, thrombophilia), or obstetric complications (gestational hypertension, preeclampsia, gestational diabetes) were excluded. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women diagnosed with mild-moderate IP and randomly selected low-risk singleton pregnancies without polyhydramnios were included in the study one-on-one by matching their gestational ages.
Key inclusion criteria (1 listed)
- Pregnant women diagnosed with mild-moderate IP ,selected low-risk singleton pregnancies without polyhydramnios
Key exclusion criteria (1 listed)
- Women who had chromosomal or anatomical abnormalities, multiple pregnancies, oligohydramnios (AFI 5 cm), severe polyhydramnios, fetal growth restriction, elective cesarean section (CS), pre-existing conditions (hypertension, diabetes, thrombophilia), or obstetric complications (gestational hypertension, preeclampsia, gestational diabetes) were excluded
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 |
|---|---|---|
| doppler assesmentIn all cases, the measurement, including UA PI and MCA PI, was measured with a 6-4 MHz convex transabdominal probe. All measurements were made by an obstetrician (Ş.D.) with 28 years of experience. Doppler measurements were collected from the proximal third of the MCA and the free-floating segment of the umbilical cord, ensuring that the angle of insonation was as close to zero as feasible and that fetal movements were absent | Diagnostic test | Idiopathic Polyhydramios Cases, low-risk pregnant women |
Primary outcome
perinatal outcome
Time frame: 1 year
adverse perinatal outcome: The week of birth and type of birth of all pregnant women participating in the study will be recorded. Premature birth rates and reasons for cesarean section will be questioned in all pregnant women. Birth weights of all neonates, 1st and 5th minute Apgar scores, and admissions to the neonatal intensive care unit will be recorded. Necessary statistical evaluation will be made in all healthy and polyhydramnios cases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Yes. shared when the work is completed
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.
şükran doğru principal investigator
NECMETTİN ERBAKAN UNIVERCITY
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 Idiopathic Polyhydramios Cases, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 18 Jan 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perinatal outcome (time frame: 1 year). 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 18 Jan 2024.