search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


RIPC and labour pain


- candidate number28074
- NTR NumberNTR6768
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-okt-2017
- Secondary IDsNL61233.091.17 
- Public TitleRIPC and labour pain
- Scientific TitleRemote ischemic preconditioning for pain management in labour: a randomized controlled pilot study
- ACRONYMRIPC and labour pain
- hypothesisRemote ischemic preconditioning as a non-invasive, non-pharmacological method for pain relief during labour
- Healt Condition(s) or Problem(s) studiedLabour pain, Remote ischemic preconditioning (RIPC)
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-jul-2018
- Target number of participants40
- InterventionsRandomization 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.
- Primary outcomeThe 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
- TimepointsThis 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.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. V.D. Linssen
- CONTACT for SCIENTIFIC QUERIESDrs. V.D. Linssen
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- Publications
- Brief summaryRationale: 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
- Main changes (audit trail)
- RECORD24-okt-2017 - 11-nov-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl