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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Camille TROUILLET
- Telefonnummer: +33 3 20 99 31 31
- E-post: urc@ch-roubaix.fr
Studieorter
-
-
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Roubaix, Frankrike, 59100
- CH de Roubaix
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Kontakt:
- Caroline GUERY, Doctor
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Akupunkturarm
Akupunkturterapi
|
9 acupuncture points will be used to managed time delivery, pain and improved patient's experience
|
|
Inget ingripande: Kontrollarm
vanlig skötsel
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Impact of 9 acupuncture points on time to delivery
Tidsram: 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
|
Day 1
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Utvärdera konsumtionen av analgetika mellan de 2 grupperna
Tidsram: Dag 1
|
data om analgetikaförbrukning kommer att samlas in i patientjournalen
|
Dag 1
|
|
Evaluate the impact of acupuncture on patient pain.
Tidsram: 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.
|
Day 1
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Evaluate experiences of the patient during labor induction between the 2 groups
Tidsram: Day 1
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Use of a questionnary with lickert scale (Completely, Sufficiently, Insufficiently, Not at all)
|
Day 1
|
|
Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups
Tidsram: Day 2
|
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
Tidsram: 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
Tidsram: Day 2
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Duration in hours between begenning of labour and delivery recorded in patients' medical records
|
Day 2
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-007
- 2026-A01789-42 (Annan identifierare: ANSM)
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