Best timing of a cesarean section in non-progressing labour|
|- candidate number||22940|
|- NTR Number||NTR5543|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-okt-2015|
|- Secondary IDs||80-84300-98-63004 ZonMw|
|- Public Title||Best timing of a cesarean section in non-progressing labour|
|- Scientific Title||Randomized controlled trial comparing the currently used Friedman partogram with a four hour action line to the newly developed SIMPLE partogram, based on the 95th percentile normogram of the Consortium on Safe Labor to evaluate early versus delayed cesarean section.|
|- ACRONYM||SIMPLE III|
|- hypothesis||A cesarean section performed without a clear indication results in additional morbidity and costs without improvement of outcome. The group of women delivering their first baby in cephalic presentation at term is the largest contributor to the caesarean section rate. In about 11% of all deliveries, women are diagnosed with non-progressing labour resulting in a caesarean section in 45% (SIMPLE I study), making it one of the most important indications for a cesarean section. Although in the Netherlands about 6400 cesarean sections are annually performed based on non-progressing labour, with 30 million euro in direct costs only, the actual moment of diagnosis and timing of a cesarean for this indication is still unclear. The second largest group contributing to the cesarean section rate are women with a previous cesarean section. Reducing the number of cesarean sections in the first pregnancy, reduces the number in the consecutive one by at least 50%. Normal duration of delivery is described in a nomogram with an action line of deviation resulting in a partogram that dictates at what point action should follow. The currently used partogram by Friedman with a four hour action line is based on a small dataset of women of more than 50 years ago. Recently the Consortium on Safe Labor has revised the cartogram based on more than 60.000 women in labour who delivered vaginally with favorable neonatal outcome. This nomogram showed that labour with normal outcome in most cases is longer than was previously assumed. Currently, intervention occurs when the Friedman action line is crossed after all regular measures have been taken. This results in early intervention and even possible a cesarean section that is performed too early than necessary. |
|- Healt Condition(s) or Problem(s) studied||Failure to progress, Caesarean section, Morbidity, Diagnosis|
|- Inclusion criteria||Nulliparous|
≥ 37 weeks of pregnancy
≥ 4 cm dilatation
Non-progressing labour (<1cm/hour)
|- Exclusion criteria||< 18 years of age|
Unable to read or understand informed consent
Fetus with relevant congenital malformation
Planned caesarean section
Non reassuring fetal condition
Inadequate pain medication (as judged by the women herself, no absolute need for epidural, but pain needs to be considered manageable for continuation of delivery)
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2015|
|- planned closingdate||1-dec-2018|
|- Target number of participants||2388|
|- Interventions||When after all regular interventions for non-progressing labour (amniotomy, oxytocin augmentation, empty bladder, pain medication) the Friedman partogram action line is crossed, randomization occurs in which performing a cesarean section is the regular conduct. In women in the intervention group is waited until the Simple cartogram action line is crossed (based on the 95th percentile of the nomogram of the Consortium on Safe Labor).|
|- Primary outcome||Mortality and composite morbidity: maternal IC admittance, Apgar score <7 after 5 minutes, pH <7.10, NICU admittance.|
|- Secondary outcome||Delivery mode, Shoulder dystocia, Anal sphincter lesions, Blood loss, Need for blood transfusion, Maternal infection, Neonatal infection, Duration of admission to the hospital, Total number of caesarean sections in the target population (including non participating women). Furthermore cost evaluation, budget impact, patient preference and patient satisfaction.
|- Timepoints||6 months follow-up from baseline (delivery).|
- Discrete choice experiment to measure patient preference (300 patients) : 6 and 12 weeks of follow up.
- Cost questionnaire (300 patients): baseline, 3 and 6 months of follow up.
- Health related quality will be measured using the EQ-5D (300 patients): baseline, 7 days, 3 and 6 months of follow up.
- Patient satisfaction questionnaire in the first week after delivery
|- Trial web site||http://www.studies-obsgyn.nl/simple3|
|- CONTACT FOR PUBLIC QUERIES||Dr. H.C.J. Scheepers|
|- CONTACT for SCIENTIFIC QUERIES||Dr. H.C.J. Scheepers|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+), NVOG|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||RATIONALE|
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%.
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.
Multi-centre randomised controlled trial
Term nulliparous women with a singleton pregnancy and a child in cephalic presentation.
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).
MAIN STUDY PARAMETERS/ENDPOINTS
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 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.
|- Main changes (audit trail)|
|- RECORD||4-okt-2015 - 31-aug-2017|
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