To compare the currently used Friedman partogram (FP) to the newly developed SIMPLE partogram (SP), based on the normogram of the consortium on Safe Labor, for the diagnosis and treatment of non-progressing labour.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome will be mortality and composite severe morbidity (maternal
intensive care admittance, Apgar score <7 after 5 minutes, pH <7.10, neonatal
intensive care admittance).
Secondary outcome
Secondary outcome will be the mode of delivery, shoulder dystocia, anal
sphincter lesion, duration of admission to the hospital, blood loss, need for
blood transfusion and maternal- and neonatal infection. Also the total number
of caesarean sections in the target population (including non-participating
women) will be analysed. Furthermore, cost effectiveness, budget impact,
patient preference and patient satisfaction will be part of the secondary
outcome.
Background summary
A caesarean section performed without a clear indication results in additional
morbidity and costs without improvement of outcome. The group of women
delivering their first baby is the largest contributor to the caesarean section
rate (31% of all caesarean sections in the Netherlands, 10.000 annually). In
about 11% of all deliveries in second line care, women are diagnosed with
non-progressing labour, resulting in a caesarean section in 45% (SIMPLE I).
This makes non-progressing labour one of the most important indications for a
caesarean section. Although in the Netherlands about 6400 caesarean sections
are annually performed based on non-progressing labour, the actual moment of
diagnosis and timing of the caesarean section in this group is still unclear.
The second largest group contributing to the caesarean section rate are women
with a previous caesarean section. Reducing the number of caesarean sections in
the first pregnancy reduces the number in the following one by at least 50%.
Study objective
To compare the currently used Friedman partogram (FP) to the newly developed
SIMPLE partogram (SP), based on the normogram of the consortium on Safe Labor,
for the diagnosis and treatment of non-progressing labour.
Study design
Multi-centre randomised controlled trial
Intervention
When after regular interventions (rupture of membranes, adequate pain
medication, oxytocin augmentation, empty bladder) the Friedman partogram is
crossed, randomisation occurs between performing a caesarean section (control
group) and waiting until the Simple partogram action line is crossed
(intervention group).
Study burden and risks
The control group receives care as usual (caesarean section when the Friedman
partogram action line is crossed), with no additional risks. Waiting until the
Simple partogram action line is crossed (intervention group) might give a
higher composite morbidity rate, which will be the main study outcome. No
additional medication or blood samples will be taken. Nor will there be extra
visits. Patients will be asked to fill in a questionnaire to measure patient
satisfaction.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Nulliparous
Singleton pregnancy
Cephalic presentation
* 37 weeks of pregnancy
* 4 cm dilatation
Non-progressing labour (passing the Friedman partogram action line)
Pain considered manageable for continuation of delivery
Exclusion criteria
< 18 years of age
Unable to read or understand informed consent
Fetus with relevant congenital malformation that can influence the delivery
mode OR have a higher risk of NICU admittance
Indication for a caesarean section due to fetal distress
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55102.068.15 |