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Best timing of a cesarean section in non-progressing labour

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26046
Enrollment
2388
Registered
2015-10-04
Start date
2015-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-progressing labour (niet vorderende ontsluiting) Diagnosis (diagnose) Cesarean section (keizersnede) Morbidity (morbiditeit)

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 i

Sponsors

Maastricht University Medical Centre + NVOG Consortium 2.0
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Nulliparous Singleton pregnancy Cephalic presentation &#8805; 37 weeks of pregnancy &#8805; 4 cm dilatation Non-progressing labour (<1cm/hour)

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Mortality and composite morbidity: maternal IC admittance, Apgar score <7 after 5 minutes, pH <7.10, NICU admittance.

Secondary

MeasureTime frame
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.

Contacts

Public ContactH.C.J. Scheepers

Maastricht Universitair Medisch Centrum+

hcj.scheepers@mumc.nl043-3874768

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)