Cerebroplacental Ratio and Perinatal Outcomes in Mild and Moderate Idiopathic Polyhydramios Cases

NCT ID: NCT06211855

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-11-30

Brief Summary

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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

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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

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Idiopathic Polyhydramios Cases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

doppler assesment

Intervention Type DIAGNOSTIC_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

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.

doppler assesment

Intervention Type DIAGNOSTIC_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

Interventions

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doppler assesment

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Pregnant women diagnosed with mild-moderate IP ,selected low-risk singleton pregnancies without polyhydramnios

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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şükran doğru

medical doctor, fellowship

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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şükran doğru

Role: PRINCIPAL_INVESTIGATOR

NECMETTİN ERBAKAN UNIVERCITY

Locations

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Necmettin Erbakan University

Meram, Konya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023/4702 (17181

Identifier Type: -

Identifier Source: org_study_id

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