Fetal distress during the second stage of labor.
Conditions
Interventions
Trade Name: Medicinal oxygen
In Dutch: Zuurstof medicinaal gasvormig SOL 100 % v/v medicinaal gas, samengeperst
Product Name: Medicinal oxygen
Product Code: RVG 30866
Pharmaceutical Form: Inhalation
Sponsors
Máxima Medisch Centrum
Eligibility
Sex/Gender
All
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 language - Informed consent obtained Fetal factors: - Singleton fetus - Fetus in head position - Suspected fetal distress (Suboptimal or Abnormal CTG according to the FIGO guideline) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Maternal factors: - Age 41+6 weeks) - Planned caesarean section Fetal factors: - Multiple fetuses - Suspected growth restriction (<p10) - Suspected infection - Congenital malformations - Breech position
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: the primary objective is to investigate the effect of maternal hyperoxygenation with 100% oxygen on fetal heart rate pattern. We will describe the difference in FHR deceleration depth, duration and frequency, baseline and variability 10 minutes before and after maternal oxygen administration. ;Secondary Objective: Secondary Objectives: venous and arterial umbilical cord blood gas analysis (pH, lactate, base excess, pO2 and pCO2), Apgar-score, fECG, mode of delivery, NICU-admissions and markers for free oxygen radical production (8-isoprostane, hypoxanthine and malondialdehyde) and catecholamines in venous and arterial umbilical cord blood, and maternal complaints. ;Primary end point(s): Fetal heart rate pattern: frequency, depth and duration of decelerations, variability and baseline will be determined before and after oxygen administration. The frequency of decelerations and FHR baseline will be determined manually. Variability and deceleration depth and duration will be determined by a computer program (MatLab). The outcome for deceleration depth and duration will be determined by calculation the area under the curve of each deceleration.;Timepoint(s) of evaluation of this end point: For study purposes, the cardiotocogram (including fetal heart rate tracing) will be stored in a computer and analysed when all subjects are included in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Umbilical cord pH (arterial and venous), base excess, lactate, pO2 and pCO2 - Apgar score - Mode of delivery - fECG - NICU admission - Markers for free oxygen radicals in arterial and venous umbilical cord blood - Catecholamines in arterial and venous umbilical cord blood - Maternal complaints ;Timepoint(s) of evaluation of this end point: Umbilical cord blood is taken immediately after birth. Blood gas analyses is performed immediately after birth (commom practice), while markers for free oxygen radical activity and cathecholamines are examined when samples from all patients are taken (these samples will be stored in the meantime). Apgar score is given within 10 minutes after birth. Mode of delivery, NICU admission, maternal complaints and baseline characteristics (for example fetal weight and sex) are noted directly after the delivery. f ECG analyses is perfomed when all patients are included in the study (analysis is perfomed on stored FHR tracings). | — |
Countries
Netherlands
Contacts
Public ContactPrincipal investigator
Máxima Medisch Centrum
Outcome results
None listed