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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Camille TROUILLET
- Telefonnummer: +33 3 20 99 31 31
- E-mail: urc@ch-roubaix.fr
Studiesteder
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Roubaix, Frankrig, 59100
- CH de Roubaix
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Kontakt:
- Caroline GUERY, Doctor
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde 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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Akupunktur arm
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 indgriben: Kontrolarm
sædvanlig pleje
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Evaluer forbruget af analgetika mellem de 2 grupper
Tidsramme: Dag 1
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data om smertestillende forbrug vil blive indsamlet i patientjournalen
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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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-007
- 2026-A01789-42 (Anden identifikator: ANSM)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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