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

NCT04744168 | Completed

• 1 other identifier: IDRCB 2020-A03023-36
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Beyond 41 Week's Gestation

Keywords

Bishop's score; Maturation; Acupuncture; Pregnancy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Rate spontaneous labour

  At 41 weeks 5 days of amenorrhea

• Duration labor

  At 41 weeks 5 days of amenorrhea

• Rate of delivery with medical intervention

  At 41 weeks 5 days of amenorrhea

• Rate of delivery by cesarean

  At 41 weeks 5 days of amenorrhea

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Placebo acupuncture

PLACEBO COMPARATOR

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

Interventions

Acupuncture OTHER

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

Acupuncture

Placebo Acupuncture OTHER

Puncture of point HM

Placebo acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Women will be distributed randomly in the experimental or the placebo arm. They won't know that the point 16 HM isn't effective on cervix maturation. They will believe that both techniques work.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 8, 2021
• Study Start: March 9, 2021
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)