COOKACUPAIN 2 : Impact of Acupuncture on Delay of Delevery During Induced Labor With Cook's Balloon at the Beaumont Maternity in Roubaix

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier de Roubaix

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

patient having contraindication for the use of Cook's balloon

patients under curatorship and/or guardianship

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture therapy

    Other intervention

    9 acupuncture points will be used to managed time delivery, pain and improved patient's experience

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Acupuncture armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Impact of 9 acupuncture points on time to delivery

The primary objective will be assessed by recording the time of COOK balloon placement and the time of delivery

Time frame
Day 1

Secondary outcomes

1

Evaluate the impact of acupuncture on patient pain.

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.

Time frame
Day 1
2

Evaluate experiences of the patient during labor induction between the 2 groups

Use of a questionnary with lickert scale (Completely, Sufficiently, Insufficiently, Not at all)

Time frame
Day 1
3

Evaluate the consumption of analgesics between the 2 groups

datas of analgesics consumption will be collected in patient record

Time frame
Day 1
4

Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups

percentage of Caesarean sections recorded in patients' medical records

Time frame
Day 2

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: