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

Completed

• Conditions: Idiopathic Polyhydramios Cases
• Interventions: Diagnostic Test: doppler assesment

• Registration Number: NCT06211855
• Lead Sponsor: Necmettin Erbakan University

Brief 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

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 Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-07
• Study First Submitted QC: 2024-01-16
• Last Update Submitted: 2024-01-16
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
low-risk pregnant women	doppler assesment	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.
Idiopathic Polyhydramios Cases	doppler assesment	The group with polyhydramnios was divided into two groups according to whether the CPR value was below 1.08 or 1.08 and above

Primary Outcome Measures

Name	Time	Method
perinatal outcome	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.

Trial Locations

Locations (1)

Necmettin Erbakan University; 🇹🇷 Meram, Konya, Turkey