Skip to content

EFFECT OF TWO DRUGS ON TONE OF UTERUS AND FETAL HEART RATE FOR PAIN RELIEF DURING LABOUR

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/08/006144
Enrollment
30
Registered
2015-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Healthy parturients aged 18-35 years with term pregnancy with single live fetus at spontaneous onset of labour, cervical dilatation of 3-5cms

Interventions

Intervention1: group BF-Bupivacaibe 2.5mg and fentanyl 15micg: Intrauterine pressure transducer from The Sonicaidâ?¢ FM800 Encore (Huntleigh Healthcare Ltd, Cardiff, UK.)Pressure recording was carried

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion 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

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 • severe anaemia (Hb • valvular heart disease. 7. severe fetal growth restriction (estimated fetal weight 8. any known allergy to local anaesthetics.

Design outcomes

Primary

MeasureTime frame
an increase of 10 mm Hg or more in basal uterine tone following administration of study drugTimepoint: 20 mins

Secondary

MeasureTime frame
1.Episodes of suspicious or pathological CTG until 30 minutes following analgesia. 2.Time to onset of satisfactory analgesia. (VAS3) 3.Incidence of hypotension/total dose of phenylephrine used. 4.Incidence of nausea/ vomiting/ pruritis. Nausea/ vomiting/ pruritis 5. Incidence of motor block 6. Postdural puncture headache Timepoint: 20 min

Countries

India

Contacts

Public ContactKAJAL JAIN

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH

ashdoctor.kuberan@gmail.com7087009539

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026