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Intrauterine resuscitation during term labor by maternal hyperoxygenation: a pilot study

Intrauterine resuscitation during term labor by maternal hyperoxygenation: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21613
Enrollment
116
Registered
2015-10-20
Start date
2015-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Fetal distress, maternal hyperoxygenation, labor, intrauterine resuscitation.

Interventions

In case of suboptimal or abnormal FHR patterns (according to the FIGO classification) during the second stage of labor, 100% oxygen is applied to the mother by a non-rebreathing mask, and continued un

Sponsors

Maxima Medical Center, Veldhoven, The Netherlands.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Maternal factors: - Age > 18 years - In term labor (gestational age 37+0 - 41+6 weeks) - Intention for vaginal delivery - Ability to understand the Dutch or English language - Informed consent obtained Fetal factors: - Singleton fetus - Fetus in cephalic presentation - Suboptimal or abnormal FHR pattern (according to FIGO classification, with exception of prolonged fetal bradycardia)

Exclusion criteria

Exclusion criteria: Maternal factors: - Age 41+6 weeks) - Planned caesarean section Fetal factors: - Multiple fetuses - Suspected infection - Congenital malformations - Breech presentation - Normal or preterminal FHR pattern, or prolonged fetal bradycardia (according to FIGO classification)

Design outcomes

Secondary

MeasureTime frame
Secondary outcome measures are arterial and venous umbilical cord pH, base excess, lactate, pO2 and pCO2, Apgar score, mode of delivery, neonatal intensive care unit (NICU) admission, markers for free oxygen radical production and maternal side effects of oxygen admission and reasons for discontinuation.

Primary

MeasureTime frame
The primary outcome measure is FHR pattern (frequency, depth and duration of decelerations, baseline and variability).

Contacts

Public ContactLauren Bullens

Berkven 36

Laurenbullens@gmail.comTel: 0031 624225377

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)