Intrauterine resuscitation during term labor by maternal hyper oxygenation: a pilot study.

Intrauterine resuscitation during term labor by maternal hyper oxygenation: a pilot study. - INTEREST-O2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44980

Enrollment

116

Registered

2015-08-19

Start date

2016-03-02

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

nonreassuring fetal condition Suspected fetal distress

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Maternal factors: - Age > 18 years - In term labor (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 head position - Suboptimal or abnormal CTG

Exclusion criteria

Exclusion criteria: Maternal factors: - Age 41+6 weeks) - Planned caesarean section;Fetal factors: - Multiple foetuses - Suspected intrauterine infection - Congenital malformations - Breech position

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is fetal heart rate pattern (frequency, depth and duration of decelerations).	—

Secondary

Measure	Time frame
Secondary outcome measures are umbilical cord (arterial and venous) pH, base excess, lactate, pO2 and pCO2, Apgar-score, mode of delivery, neonatal intensive care unit admission, markers for free oxygen radical production in umbilical cord blood and fetal ECG. Experience of participants with participating in this study.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)