NCT04744168

Acupuncture Effect on the Rate of Maturation in Post Term Pregnancies.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Centre Hospitalier Sud Francilien · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Brief Summary Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis. (Limit: 5000 characters) Example: The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both ears due to autoimmune inner ear disease (AIED). The first purpose of this randomized study is to determine if five points of acupuncture : 4GI, 6RP, 34VB, 36E, 3F could improve the bishop score for prolonged pregnancies and decrease the rate of maturation. The protocol of our study consists of proposing to the pregnant women one or two acupuncture sessions the term's day and three days later. Once the consent is signed, women are randomly included in the experimental or placebo arm. In the experimental arm, midwives puncture five points : 4GI, 6 RP, 34VB, 36E, 3F on each side while in the placebo arm, they puncture just one point : 16 HM on each side. The maturation's rate between the two groups will be compared by a Fisher's exact test and analyzed in function parity (nulliparous or multiparous) and number of sessions (one or two) with a model of univariate and multivariate logistic regression.

Detailed description

In maternity hospital center Corbeil-Essonnes, pregnant women have two monitoring consultations at term and three days later if they don't deliver between the two. At 41 weeks of amenorrhea and five days, women are convened in maternity for induction labour. Midwife determined Bishop's score with a vaginal exam to choose between a cervix's maturation (if bishop's score \<5) or an induction of labour by oxytocin (if bishop's score\>5). The protocol of study consists of proposing to the pregnant women one or two acupuncture sessions the term's day and three days later. Once the consent is signed, women are randomly included in the experimental or placebo arm. In the experimental arm, midwives puncture five points : 4GI, 6 RP, 34VB, 36E, 3F on each side while in the placebo arm, they puncture just one point : 16 HM on each side. At each consultation, the midwife collects the bishop's score to compare the average of it between the two arms and evaluate the rate of maturation. The maturation's rate between the two groups will be compared by a Fisher's exact test and analyzed in function parity (nulliparous or multiparous) and number of sessions (one or two) with a model of univariate and multivariate logistic regression. Finally, the average duration of induction labour will analyze, duration of labour and delivery route between the two arms.

Conditions

• Pregnancy Beyond 41 Week's Gestation

Interventions

Type	Name	Description
OTHER	Acupuncture	Puncture of 5 points 4GI, 6RP, 34VB, 36E, 3F
OTHER	Placebo Acupuncture	Puncture of point HM

Timeline

• Start date: 2021-03-09
• Primary completion: 2021-09-16
• Completion: 2021-09-16
• First posted: 2021-02-08
• Last updated: 2021-09-22

Locations

1 site across 1 country: France