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

NCT ID: NCT04744168

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2021-09-16

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Acupuncture

In the experimental arm, pregnant women at term will benefit one or two acupuncture sessions with five points : 4GI, 6RP, 34VB,36E,3F. The first session at 41 amenorrhea weeks and the second at 41 amenorrhea weeks and 3 days if they are not delivered between the both.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Puncture of 5 points 4GI, 6RP, 34VB, 36E, 3F

Placebo acupuncture

In the placebo arm, pregnant women will benefit one or two acupuncture sessions with one point which is located outside the acupuncture meridian.

The first session at 41 amenorrhea weeks and the second at 41 amenorrhea weeks and 3 days if they are not delivered between the both.

Group Type: PLACEBO_COMPARATOR

Placebo Acupuncture

Intervention Type: OTHER

Puncture of point HM

Interventions

Acupuncture

Puncture of 5 points 4GI, 6RP, 34VB, 36E, 3F

Intervention Type: OTHER

Placebo Acupuncture

Puncture of point HM

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Nulliparous or multipares with physiological pregnancy at 41 weeks
• Cephalic foetal presentation,
• Healthy or unicicatricial uterus,
• Major patientes,
• Speaking french,
• Term of the pregnancy determinated with a dating ultrasound between 11 weeks and 13 weeks+ 6 days,
• Having signed the form of consent participation.

Exclusion Criteria

• Foetal or maternal diseases requiring a maturation before 41 weeks : pre eclampsia, pre-existing diabetes, imbalance gestational diabetes, threat premature delivery treat with tocolytic, macrosomia or intrauterine growth retardation,
• Diseases discoveries at 41 weeks : pre eclampsia, moves of the baby decrease, low amniotic fluid,anomalies of the foetal heartbeat
• Circled pregnancy,
• Twins or more,
• Foetal death in utero, medical termination of pregnancy,
• Unstuck membranes,
• Minor patients
• Patients who benefited acupuncture during pregnancy ,
• Imprecise term of delivery,
• Podalic presentation
• Patients under supervision or curatorship,
• Patients without social security.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Countries

France

Other Identifiers

IDRCB 2020-A03023-36

Identifier Type: -

Identifier Source: org_study_id