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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Beyond 41 Week's Gestation
• Intervention / Treatment: Other: Acupuncture; Other: Placebo Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Corbeil-essonnes Cedex, France, 91106
    • Centre Hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Acupuncture; Puncture of 5 points 4GI, 6RP, 34VB, 36E, 3F
Placebo Comparator: 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.	Other: Placebo Acupuncture; Puncture of point HM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bishop score	cervix score is a pre-labor scoring system to assist in predicting whether induction of labor will be required (The highest possible score is 13 and the lowest possible score is 0)	At 41 weeks of amenorrhea
Bishop score	cervix score is a pre-labor scoring system to assist in predicting whether induction of labor will be required	3 days after the term of pregnancy
Bishop score	cervix score is a pre-labor scoring system to assist in predicting whether induction of labor will be required	5 days after the term of pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate spontaneous labour	comparison of spontaneous labour's number in the two groups between 41 weeks of amenorrhea and 41 weeks of amenorrhea and five days.	At 41 weeks 5 days of amenorrhea
Duration labor	comparison of average number of hours between entry into the delivery room and the delivery, in the two groups.	At 41 weeks 5 days of amenorrhea
Rate of delivery with medical intervention	comparison medical intervention's number in the two groups.	At 41 weeks 5 days of amenorrhea
Rate of delivery by cesarean	comparison cesarean's number in the two groups	At 41 weeks 5 days of amenorrhea

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): September 16, 2021
• Study Completion (Actual): September 16, 2021

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Acupuncture; Pregnancy; Maturation; Bishop's score
• Additional Relevant MeSH Terms: Pregnancy Complications; Pregnancy, Prolonged
• Other Study ID Numbers: IDRCB 2020-A03023-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No