Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04744168
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2021-01-22
Brief Title:
Acupuncture Effect on the Rate of Maturation in Post Term Pregnancies
Sponsor:
Centre Hospitalier Sud Francilien
Organization:
Centre Hospitalier Sud Francilien
Study Overview
Official Title:
Acupuncture Effect on the Rate of Maturation in Post Term Pregnancies
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATUPUNCTURE
Brief 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 terms 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 maturations rate between the two groups will be compared by a Fishers 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
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 terms 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 maturations rate between the two groups will be compared by a Fishers 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 dont deliver between the two At 41 weeks of amenorrhea and five days women are convened in maternity for induction labour Midwife determined Bishops score with a vaginal exam to choose between a cervixs maturation if bishops score 5 or an induction of labour by oxytocin if bishops score5
The protocol of study consists of proposing to the pregnant women one or two acupuncture sessions the terms 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 bishops score to compare the average of it between the two arms and evaluate the rate of maturation
The maturations rate between the two groups will be compared by a Fishers 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
The protocol of study consists of proposing to the pregnant women one or two acupuncture sessions the terms 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 bishops score to compare the average of it between the two arms and evaluate the rate of maturation
The maturations rate between the two groups will be compared by a Fishers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None