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

Phase 3

Completed

Conditions: nonreassuring fetal condition
Suspected fetal distress
10010273

Registration Number: NL-OMON44980

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 116

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is fetal heart rate pattern (frequency, depth and<br /><br>duration of decelerations).</p><br>

Secondary Outcome Measures

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