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

Primary Purpose

Pregnancy Beyond 41 Week's Gestation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Acupuncture
Placebo Acupuncture
Sponsored by
Centre Hospitalier Sud Francilien
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Beyond 41 Week's Gestation focused on measuring Bishop's score, Maturation, Acupuncture, Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Centre Hospitalier Sud Francilien

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acupuncture

Placebo acupuncture

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)
Bishop score
cervix score is a pre-labor scoring system to assist in predicting whether induction of labor will be required
Bishop score
cervix score is a pre-labor scoring system to assist in predicting whether induction of labor will be required

Secondary Outcome Measures

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.
Duration labor
comparison of average number of hours between entry into the delivery room and the delivery, in the two groups.
Rate of delivery with medical intervention
comparison medical intervention's number in the two groups.
Rate of delivery by cesarean
comparison cesarean's number in the two groups

Full Information

First Posted
January 22, 2021
Last Updated
September 21, 2021
Sponsor
Centre Hospitalier Sud Francilien
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1. Study Identification

Unique Protocol Identification Number
NCT04744168
Brief Title
Acupuncture Effect on the Rate of Maturation in Post Term Pregnancies.
Acronym
MATUPUNCTURE
Official Title
Acupuncture Effect on the Rate of Maturation in Post Term Pregnancies.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
September 16, 2021 (Actual)
Study Completion Date
September 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Sud Francilien

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Beyond 41 Week's Gestation
Keywords
Bishop's score, Maturation, Acupuncture, Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm 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.
Arm Title
Placebo acupuncture
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Puncture of 5 points 4GI, 6RP, 34VB, 36E, 3F
Intervention Type
Other
Intervention Name(s)
Placebo Acupuncture
Intervention Description
Puncture of point HM
Primary Outcome Measure Information:
Title
Bishop score
Description
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)
Time Frame
At 41 weeks of amenorrhea
Title
Bishop score
Description
cervix score is a pre-labor scoring system to assist in predicting whether induction of labor will be required
Time Frame
3 days after the term of pregnancy
Title
Bishop score
Description
cervix score is a pre-labor scoring system to assist in predicting whether induction of labor will be required
Time Frame
5 days after the term of pregnancy
Secondary Outcome Measure Information:
Title
Rate spontaneous labour
Description
comparison of spontaneous labour's number in the two groups between 41 weeks of amenorrhea and 41 weeks of amenorrhea and five days.
Time Frame
At 41 weeks 5 days of amenorrhea
Title
Duration labor
Description
comparison of average number of hours between entry into the delivery room and the delivery, in the two groups.
Time Frame
At 41 weeks 5 days of amenorrhea
Title
Rate of delivery with medical intervention
Description
comparison medical intervention's number in the two groups.
Time Frame
At 41 weeks 5 days of amenorrhea
Title
Rate of delivery by cesarean
Description
comparison cesarean's number in the two groups
Time Frame
At 41 weeks 5 days of amenorrhea

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-essonnes Cedex
ZIP/Postal Code
91106
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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