The treatment of suspected fetal hypoxia during labor by administration of additional oxygen to the mother.

Phase 1

• Conditions: Fetal distress during the second stage of labor.; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2015-001654-15-NL
• Lead Sponsor: Máxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-25
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 50

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

Maternal factors:
-Age < 18 years
-Use of any of the following medication: corticosteroids, antihypertensives, magnesiumsulphate, amiodaron, opioids, 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 fetuses
-Suspected growth restriction (-Suspected infection
-Congenital malformations
-Breech position

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified