COOKACUPAIN 2 : Impact of Acupuncture on Delay of Delevery During Induced Labor With Cook's Balloon at the Beaumont Maternity in Roubaix (COOKACUPAIN 2)
Impact of Acupuncture on Delay of Delevery During Induced Labor With Cook's Balloon at the Beaumont Maternity in Roubaix
In France, labor induction rate is above 25.8%. Labor induction with Cook's balloon is a non-hormonal mechanical method.
At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this labor induction.
No studies where found about an effect of acupuncture therapy on delivery provoked by labor induction with Cook's balloon.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Investigators aim to demonstate that acupuncture therapy during labor induction with Cook's balloon can reduced delay until delivery and improved patient's experience. Investigators will use 9 acupuncture points (7C bilateral/ 34VB bilateral/ 3F bilateral, 4GI bilateral and 4VC bilateral) before the application of the balloon. A visual analog scale will be used before and after balloon insertion to collect pain level.
A questionnary will be filled by patient to collect their experiences. Investigators will collect data about analgesia, failed of induction and cesarean section to see effect of acupuncture on them.
Patients will be randomised.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Camille TROUILLET
- Telefonnummer: +33 3 20 99 31 31
- E-post: urc@ch-roubaix.fr
Studiesteder
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Roubaix, Frankrike, 59100
- CH de Roubaix
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Ta kontakt med:
- Caroline GUERY, Doctor
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- pregnant woman with a gestational age of 37 weeks and above
- age>=18 years old
- having medical indication to be labor induced by Cook's Balloon
- speaking French
- agreeing to participate by signing informed consent form
Exclusion Criteria:
- patient having contraindication for the use of Cook's balloon
- patients under curatorship and/or guardianship
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Akupunkturarm
Akupunktur terapi
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9 acupuncture points will be used to managed time delivery, pain and improved patient's experience
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Ingen inngripen: Kontrollarm
vanlig omsorg
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Impact of 9 acupuncture points on time to delivery
Tidsramme: Day 1
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The primary objective will be assessed by recording the time of COOK balloon placement and the time of delivery
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Day 1
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Vurder forbruket av analgetika mellom de 2 gruppene
Tidsramme: Dag 1
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data om smertestillende forbruk vil bli samlet inn i pasientjournalen
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Dag 1
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Evaluate the impact of acupuncture on patient pain.
Tidsramme: Day 1
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Assessment of patient pain using Visual Analogic Scale scores for 1 to 10 points : before insertion of the Cook balloon, one hour after insertion, upon transfer to the delivery room, and during pushing efforts.
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Day 1
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Evaluate experiences of the patient during labor induction between the 2 groups
Tidsramme: Day 1
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Use of a questionnary with lickert scale (Completely, Sufficiently, Insufficiently, Not at all)
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Day 1
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Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups
Tidsramme: Day 2
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percentage of Caesarean sections recorded in patients' medical records
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Day 2
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Comparison of balloon failure rate between the two groups
Tidsramme: Day 2
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percentage of ballon failed procedure recorded in patients' medical records
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Day 2
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Comparison of induction duration between the two groups
Tidsramme: Day 2
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Duration in hours between begenning of labour and delivery recorded in patients' medical records
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Day 2
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-007
- 2026-A01789-42 (Annen identifikator: ANSM)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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