Fetal scalp blood pH or lactate determination in the management of intrapartum fetal distress: A randomised controlled multi-centre trial

Completed

• Conditions: Intrapartum fetal monitoring; Pregnancy and Childbirth

• Registration Number: ISRCTN01606064
• Lead Sponsor: Karolinska University Hospital (c/o Lennart Nordström)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-02
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

1. Women in labour with a singleton pregnancy
2. Gestational age >34 weeks
3. Cephalic presentation
4. Clinical situation where a fetal scalp blood sampling was indicated
5. Those who had given consent

Exclusion Criteria

1. Gestational age <34 weeks
2. Breech or multiple pregnancies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of metabolic acidemia or pH less than 7.00

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures: <br>1. Protocol violation (mainly due to failed sampling or analysis)<br>2. Rate of instrumental deliveries <br>3. Rate of cesarean section <br>4. Apgar score less than 7 at 5 min<br>5. Admissions to neonatal intensive care unit<br><br>Tertiary outcome measures: <br>1. Prevalence of pH less than 7.10<br>2. Rate of intervention due to fetal distress<br>3. Rate of Hypoxic Ischemic Encephalopathy (HIE)