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

Centre Hospitalier Sud Francilien

Status: Completed

Conditions: Pregnancy Beyond 41 Week's Gestation

Treatments: Other: Acupuncture; Other: Placebo Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04744168

IDRCB 2020-A03023-36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups, including a placebo group

Acupuncture

Experimental group

Description:

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.

Treatment:

Other: Acupuncture

Placebo acupuncture

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Acupuncture