pain relief during active labour MedDRA version: 8.1 Level: HLT Classification code 10029772 Term: Normal pregnancy, labour and delivery
Conditions
Interventions
Product Name: Pethidine
Product Code: Pethidine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PETHIDINE
CAS Number: 5
Sponsors
Poole Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The women recruited will be those in active labour with a singleton pregnancy, defined as regular uterine contractions of at least 2 in 10 minutes and cervical dilatation of at least 3 cms, with fetal gestational age of 37-42 weeks and a minimum weight of 70kg. Both multiparous and nulliparous women will be studied. We will study women who have either spontaneously gone into labour or who have had an amniotomy and intravenous oxytocin to induce labour. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria include allergy or previous severe reaction to opioid analgesia, opioid dependency, history of fetal compromise, maternal cardiorespiratory compromise, ASA 3 & 4, maternal weight greater than 120kgs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Pain: (a) Pain intensity VAS (as used in Fairlie et al) (b) Average pain intensity VAS druing labour Side effects: (a) Need for neonatal resuscitation (b) Apgar Score <7 at 1 minute ; Secondary Objective: a Verbal pain intensity over first 3 hours. b Maternal sedation score over first 3 hours and Average maternal sedation score c Time from first dose to first use of syntocinon d Time from first dose to delivery e Fetal outcome f. Entonox or regional analgesia given ;Primary end point(s): Delivery | — |
Countries
United Kingdom
Outcome results
None listed