Partogram Action Line Study (PALS2)
| ISRCTN | ISRCTN78346801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78346801 |
| Secondary identifying numbers | LWH0147 |
- Submission date
- 06/07/2005
- Registration date
- 24/08/2005
- Last edited
- 27/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Tina Lavender
Scientific
Scientific
Midwifery Research Dept
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/09/1998 |
| Completion date | 31/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liverpool Women's Hospital
Liverpool Women's NHS Foundation Trust
Midwifery Research Dept
Crown Street
Liverpool
L8 7SS
United Kingdom
Midwifery Research Dept
Crown Street
Liverpool
L8 7SS
United Kingdom
Sponsor information
Liverpool Women's Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Crown Street
Liverpool
L8 7SS
England
United Kingdom
"ROR" |
https://ror.org/00eysw063 |
|---|
Funders
Funder type
Government
Liverpool Women's Hospital NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2006 | Yes | No |
