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To compare the effect of highflow oxygen among women in active labour developing fetal distress on newborn to those receiving low flow oxygen as standard care.

Effect of maternal hyperoxygenation on neonatal outcomes among women in labour with pathological cardiotocogram â?? an Open Label Randomized Controlled Trial. - HOP Activ trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033453
Enrollment
148
Registered
2021-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: O76- Abnormality in fetal heart rate and rhythm complicating labor and delivery

Interventions

Intervention1: MATERNAL HYPEROXYGENATION: PROVIDING OXYGEN AT 10L/MINUTE BY A NONREBREATHING MASK THAT ENSURES A MINIMUM OF 80% FiO2 TO THE MOTHER Control Intervention1: MATERNAL OXYGENATION: PROVIDI

Sponsors

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH PUDUCHERRY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Singleton parturient of more than or equal to 18 years of age at term (more than or equal to 37 weeks of gestation) in active phase of labour (more than 6 cm cervical dilatation) with pathological cardiotocogram admitted to labour room of JIPMER (Women and Children hospital) during the study period

Exclusion criteria

Exclusion criteria: 1. Fetal growth restriction stage 2,3 2. Fetus with Major congenital malformation 3. Any woman requiring invasive/non-invasive ventilation or inotropes 4. Previous caesarean section 5. Placental Abruption. 6. Cord prolapse 7. Chorioamnionitis

Design outcomes

Primary

MeasureTime frame
neonatal 5-minute APGAR scoreTimepoint: 5-minute Birth APGAR score—

Secondary

MeasureTime frame
Level of methylmalondialdehyde (oxidative stress marker) in cord bloodTimepoint: One time assessment;Proportion of Neonatal Intensive Care Unit (NICU) admissionTimepoint: till 7 days of life;Umbilical cord blood (Paired samples) gas pH, base deficit and lactate Timepoint: One time assessment after birth—

Countries

India

Contacts

Public ContactSRUTHY P SULAIMAN

JIPMER, Puducherry

dr.niveditajha@gmail.com9487581663

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026