Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LWH0147
Study information
Scientific title
Partogram Action Line Study (PALS2)
Acronym
PALS 2
Study hypothesis
To assess the effect of managing labour using two different partograms on maternal satisfaction and caesarean section rate
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Management of labour progress
Intervention
2 or 4 hour partogram
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Overall caesarean section rate, maternal dissatisfaction (score <15)
Secondary outcome measures
Maternal: duration of labour (randomisation-delivery interval), use of oxytocin for augmentation, postpartum haemorrhage (PPH) (>500 ml), use of analgesia, number of vaginal examinations, vaginal operative delivery rate.
Neonatal: Admission to Special Care Baby Unit (SCBU), APGAR scores (Appearance, Pulse, Grimace, Activity, Respiration) <7 at 5 min, neonatal seizures, birth asphyxia (defined as cord pH ≤7, base excess ≥12.0 mmo/l)
Overall trial start date
01/09/1998
Overall trial end date
31/08/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Gestational age >37 weeks
2. Primigravidae
3. Spontaneous labour defined as:
a. Cervix is either partically or fully effaced and >3 cm dilated
b. Regular uterine contractions are present (at least two in ten minutes >30 seconds)
4. Live baby
5. Singleton
6. Cephalic
7. Satisfactory admission cardiotocogram (CTG)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
3000
Participant exclusion criteria
1. Multigravidae
2. Insulin dependent diabetics
3. Significant fetal malformations
4. Contraindications to use of oxytocin
Recruitment start date
01/09/1998
Recruitment end date
31/08/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool Women's Hospital
Liverpool Women's NHS Foundation Trust
Midwifery Research Dept
Crown Street
Liverpool
L8 7SS
United Kingdom
Funders
Funder type
Government
Funder name
Liverpool Women's Hospital NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16880298
Publication citations
-
Lavender T, Alfirevic Z, Walkinshaw S, Effect of different partogram action lines on birth outcomes: a randomized controlled trial., Obstet Gynecol, 2006, 108, 2, 295-302, doi: 10.1097/01.AOG.0000226862.78768.5c.