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the efficacy of maternal oxygen inhalation for fetal growth restriction

Prospective study on the efficacy of maternal oxygen inhalation for fetal growth restriction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051240145
Enrollment
20
Registered
2024-10-03
Start date
2026-02-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal growth restriction Fetal growth restriction, oxygen

Interventions

Maternal oxygen inhalation for about 12 hours every day from 8 am to 8 pm [except for when eating, using the toilet and showering]. We confirm that total oxygen inhalation time for 2 days is 8 hours o
maternal oxygen inhalation

Sponsors

Katsura Daisuke
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Fetal growth restriction Estimated fetal body weight is less than or equal to -1.5 standard deviations 2. Age is 18 years or older 3. Gestational age is between 23 weeks and less than 37 weeks 4. Umbilical artery diastolic blood flow abnormalities 5. Written informed consent is obtained

Exclusion criteria

Exclusion criteria: 1. Lethal fetal anomaly and chromosomal abnormality 2. Maternal and fetal emergencies such as placental abruption, umbilical cord prolapse, non reassuring fetal status, uterine rupture etc 3. Pregnant women with high risk of venous thromboembolism [VTE] two or more episodes of VTE, undergoing anticoagulant therapy for the treatment or prevention of VTE before pregnancy, one episode of VTE with meeting any of the following criteria: thrombotic predisposition, previous thromboembolism occurred either during pregnancy or while taking estrogen 4. Undesirable to participate in this study

Design outcomes

Primary

MeasureTime frame
Improvement rate of Umbilical artery diastolic blood flow abnormalities

Secondary

MeasureTime frame
Optimal inspired oxygen concentration to improve fetal umbilical artery blood flow abnormalities Change of fetal umbilical artery blood flow abnormalities 8 hours and 12 hours after starting oxygen inhalation Changes in fetal hemodynamics [middle cerebral artery, ductus arteriosus, aorta, renal artery, ductus venosus, umbilical vein, inferior vena cava], cardiac function [Tei index, fractional shortening, total cardiac output] Presence or absence of adverse events [premature constriction of ductus arteriosus, pulmonary functional examination] Pregnancy outcome [threatened preterm labor, hypertension disorder of pregnancy, preeclampsia, non-reassuring fetal status, and intrauterine fetal death] Delivery outcome [gestational age of delivery, delivery method, delivery time, amount of blood loss during delivery, birth weight, sex, Apgar score, umbilical artery blood pH, infant's NICU admission, neonatal transient tachypnea, respiratory distress syndrome, artificial ventilation, intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, chronic lung disease, and neonatal death]

Contacts

Public ContactDaisuke Katsura

Shiga University of Medical Science Hospital

hqgyne@belle.shiga-med.ac.jp+81-77-548-2267

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026