Condition category
Pregnancy and Childbirth
Date applied
06/07/2005
Date assigned
24/08/2005
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Tina Lavender

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Liverpool Women's Hospital (UK)

Sponsor details

Crown Street
Liverpool
L8 7SS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16880298

Publication citations

  1. 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.

Additional files

Editorial Notes