To investigate the effect of maternal hyperoxygenation with 100% in the second stage of labor and in the presence of abnormal fetal heart rate (FHR) patterns on fetal condition, instrumental delivery rate and free radical production. In case a…
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Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is fetal heart rate pattern (frequency, depth and
duration of decelerations).
Secondary outcome
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.
Background summary
Perinatal asphyxia is one of the four main causes of perinatal morbidity and
mortality in the Netherlands. Small human studies of poor quality do indicate
that additional oxygen supplied to the mother in case of fetal distress
improves fetal condition during labor. In the USA maternal hyperoxygenation in
case of fetal distress is common practice and recommended by the American
College of Obstetricians and Gynecologists. However, the British guideline
recommends not to use additional oxygen for fetal distress because of the lack
of randomized studies proving its beneficial effect and potentially harmfull
effect of increased free-radical production. The Dutch guideline did not
propose any recommendation yet. Several reviews conclude that there is an
urgent need for a randomized controlled trial investigating the effect of
maternal hyperoxygenation on fetal condition. We hypothesise that the
beneficial effects on fetal oxygenation outweighs the potential increase in
free-radical production.
Study objective
To investigate the effect of maternal hyperoxygenation with 100% in the second
stage of labor and in the presence of abnormal fetal heart rate (FHR) patterns
on fetal condition, instrumental delivery rate and free radical production. In
case a positive effect on FHR pattern is shown, we will use the data obtained
from this study to design a larger, multicenter RCT to investigate the effect
on umbilical cord pH and/or Apgarscore.
Study design
Randomized controlled trial in a tertiary hospital in the Netherlands.
Intervention
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.
Study burden and risks
Continuous FHR monitoring generally takes place through a transvaginal lead
attached to the fetal head. This is common practice in all clinical deliveries.
The non-rebreathing mask fits tight to the nose and mouth which may cause some
discomfort to the parturient. High levels of inspired oxygen may cause
reversible vasoconstriction in the mothers brain of approximately 10%. This is
not expected to cause any harm. Besides, the amount of free oxygen radicals
will increase in the maternal blood. We do not expect this to cause any harm
due to the mature anti-oxygen sytem in the adult. We expect the fetus to profit
from maternal hyperoxygenation by improved pH levels and a decreased risk on
prolonged fetal hypoxia potentially resulting in perinatal asphyxia. In the
fetal blood the amount of free oxygen radicals may increase as well. Neonatal
resuscitation with 100% oxygen may lead to an increased risk of fetal
bronchopulmonary disease and retinopathy, especially in premature infants.
However, in this study preterm deliveries are excluded. Besides, the increase
in fetal pO2 due to maternal hyperoxygenation will never reach the increase as
a result of direct application of 100% oxygen to the fetus.
Besides we hypothesise that less interventions to immediately deliver the
fetus, such as episiotomy, assisted vaginal delivery or caesarean sections will
be needed. Both mothers and foetuses will profit from this effect.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
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
Maternal factors:
- Age < 18 years
- Use of the following medication: corticosteroids, antihypertensives, magnesiumsulphate, amiodaron, adriamycine, bleomycine, actinomycine, menadion, (chloor-) promazine, thiordiazine, chloroquine
- Pre-existing cardiac disease
- Pulmonary disease needing the use of medication
- Diabetes
- Hyperthyroidism
- Anemia (Hb < 6.5 mmol/l)
- Smoking, using alcohol or recreational drugs during pregnancy
- Pre- or postterm labor (< 37+0 or > 41+6 weeks)
- Planned caesarean section;Fetal factors:
- Multiple foetuses
- Suspected intrauterine infection
- Congenital malformations
- Breech position
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
EudraCT | EUCTR2015-001654-15-NL |
CCMO | NL53018.000.15 |