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Clinical Trials/CTRI/2015/08/006144
CTRI/2015/08/006144
Completed
Phase 4

A RANDOMISED DOUBLE BLIND CLINICAL TRIAL TO EVALUATE THE EFFECTS OF INTRATHECAL BUPIVACAINE OR BUPIVACAINE-FENTANYL COMBINATION ON UTERINE TONE AND FETAL HEART RATE DURING LABOUR ANALGESIA

PGIMER0 sites30 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
PGIMER
Enrollment
30
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
PGIMER

Eligibility Criteria

Inclusion Criteria

  • 1\. single live fetus with vertex presentation.
  • 2\. spontaneous onset of labour.
  • 3\.cervical dilatation of 3\-5cms.
  • 4\. normal fetal cardiotocograph.

Exclusion Criteria

  • 1\.contraindications to regional analgesia.
  • 2\.use of any other analgesia before recruitment to the study.
  • 3\.induction of labour with oxytocin or prostaglandins.
  • 4\.pre\-labour rupture of membranes.
  • 5\.previous scarred uterus (previous caesarean section or myomectomy).
  • 6\.maternal medical disorders like
  • diabetes mellitus (DM)
  • gestational DM on insulin
  • severe hypertension (BP \>\=160/110\)
  • pre\-eclampsia

Outcomes

Primary Outcomes

Not specified

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