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Remote ischemic preconditioning for pain management in labour: a randomized controlled pilot study.

Remote ischemic preconditioning for pain management in labour: a randomized controlled pilot study. - Remote ischemic Preconditioning and labour pain

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45643
Enrollment
40
Registered
2017-09-26
Start date
2018-08-23
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

pijn labour pain

Interventions

Randomization creates 2 groups. One group will undergo 3 cycles of ischemia for 5 minutes (50 mmHg above own systolic blood pressure) followed by 5 minutes of reperfusion. In the other group the tou

Sponsors

Anesthesiologie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Woman at 37-42 gestational weeks • Aged > 18 years

Exclusion criteria

Exclusion criteria: • Analgesics before study • Raynaud phenomenon • Post-traumatic lengthy hand reconstruction on both upper extremities • Severe crushing injuries on both upper extremities • Skin grafts on both upper extremities • Patients with advice for epidural analgesia • Patient with contraindications for epidural analgesia • Obstetrical complications such as: o Intrauterine fetal death o Obstetric high care patient o Bleeding disorders o Thrombosis disorders

Design outcomes

Primary

MeasureTime frame
The time between the intervention and the need for any (other) analgesia.

Secondary

MeasureTime frame
• Women with 30% or more pain relief after 10 minutes, 30 minutes, one hour and then every hour after treatment • NRS scores and analgesic needs • Rate of assisted vaginal birth • Rate of caesarean section • Apgar score • Significant maternal morbidity; major postpartum haemorrhage, uterine rupture, admission to an ICU, eclampsia or severe HELLP • Adverse and serious adverse events

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)