No registrations found.
ID
Source
Brief title
Health condition
Remote ischemic preconditioning, RIPC
Labour pain
Baringspijn, bevallingspijn, RIPC, ischemische preconditionering
Sponsors and support
Intervention
Outcome measures
Primary outcome
The time between the intervention and the need for any (other) analgesia
Secondary outcome
- 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
Background summary
Rationale: Remote ischemic preconditioning as a non-invasive, non-pharmacological method for pain relief during labour.
Objective: Reduce the need for other analgesia after RIPC by investigating the efficacy of remote ischemic preconditioning on pain during labour.
Study design: Randomized, single blinded, placebo controlled, pilot intervention study
Study population: Women > 18 years at 37-42 gestational weeks and planned for labour induction.
Intervention: 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 tourniquet pressure is 20 mmHg with the same 3 cycles and this is the control group.
Main study parameters/endpoints: The time between the intervention and the need for any (other) analgesia
Study objective
Remote ischemic preconditioning as a non-invasive, non-pharmacological method for pain relief during labour
Study design
This study requires to ask for pain and comfort scores after 10 minutes, 30 minutes, 1 hour and then every hour after the intervention till one hour after childbirth.
Intervention
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 tourniquet pressure is 20 mmHg with the same 3 cycles and this is the control group.
Afdeling Anesthesiologie <br>
Postbus 9101 <br>
6500 HB Nijmegen
V.D. Linssen
Philips van Leydenlaan 25
6525 EX Nijmegen
Nijmegen
The Netherlands
(024) 36 55653
vera.linssen@radboudumc.nl
Afdeling Anesthesiologie <br>
Postbus 9101 <br>
6500 HB Nijmegen
V.D. Linssen
Philips van Leydenlaan 25
6525 EX Nijmegen
Nijmegen
The Netherlands
(024) 36 55653
vera.linssen@radboudumc.nl
Inclusion criteria
- Woman at 37-42 gestational weeks
- Aged > 18 years
Exclusion criteria
- Analgesics < 6 hours before the study
- Raynaud phenomenon
- Systolic blood pressure > 200 mmHg
- 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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6554 |
| NTR-old | NTR6768 |
| CCMO | NL61233.091.17 |
| OMON | NL-OMON45643 |