SIMPLE III; a randomised controlled non-inferiority trial: best timing for a caesarean section in non-progressing labour;

SIMPLE III; a randomised controlled non-inferiority trial: best timing for a caesarean section in non-progressing labour; - SIMPLE III

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46322

Enrollment

2388

Registered

2016-07-04

Start date

2017-01-14

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

non-progressing labour

Interventions

When after regular interventions (rupture of membranes, adequate pain medication, oxytocin augmentation, empty bladder) the Friedman partogram is crossed, randomisation occurs between performing a c

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Primary outcome will be mortality and composite severe morbidity (maternal intensive care admittance, Apgar score	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)