Partogram Action Line Study (PALS2)

ISRCTN	ISRCTN78346801
DOI	https://doi.org/10.1186/ISRCTN78346801
Protocol serial number	LWH0147
Sponsor	Liverpool Women's Hospital (UK)
Funder	Liverpool Women's Hospital NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Tina Lavender
Scientific

Midwifery Research Dept
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Partogram Action Line Study (PALS2)
Study acronym	PALS 2
Study objectives	To assess the effect of managing labour using two different partograms on maternal satisfaction and caesarean section rate
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Management of labour progress
Intervention	2 or 4 hour partogram
Intervention type	Other
Primary outcome measure(s)	Overall caesarean section rate, maternal dissatisfaction (score <15)
Key secondary outcome measure(s)	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)
Completion date	31/08/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	3000
Key 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)
Key exclusion criteria	1. Multigravidae 2. Insulin dependent diabetics 3. Significant fetal malformations 4. Contraindications to use of oxytocin
Date of first enrolment	01/09/1998
Date of final enrolment	31/08/2005

Liverpool Women's Hospital

Liverpool Women's NHS Foundation Trust
Midwifery Research Dept
Crown Street
Liverpool
L8 7SS
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2006		Yes	No