Clinical trial NCT04744168: Acupuncture Effect on the Rate of Maturation in Post Term Pregnancies.
Official title: Acupuncture Effect on the Rate of Maturation in Post Term Pregnancies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Beyond 41 Week's Gestation
Keywords: Bishop's score
Maturation
Acupuncture
Pregnancy
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Bishop score
timeFrame: At 41 weeks of amenorrhea
measure: Bishop score
timeFrame: 3 days after the term of pregnancy
measure: Bishop score
timeFrame: 5 days after the term of pregnancy
Secondary outcomes:
measure: Rate spontaneous labour
timeFrame: At 41 weeks 5 days of amenorrhea
measure: Duration labor
timeFrame: At 41 weeks 5 days of amenorrhea
measure: Rate of delivery with medical intervention
timeFrame: At 41 weeks 5 days of amenorrhea
measure: Rate of delivery by cesarean
timeFrame: At 41 weeks 5 days of amenorrhea
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
References: