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OpenTrials
Completed

NCT Number: NCT06211855

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Necmettin Erbakan University

Meram, Konya, 42140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

doppler assesment

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2024
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.