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Completed

NCT Number: NCT04744168

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Other

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

Placebo Acupuncture

Other

Puncture of point HM

Primary outcomes

  1. Bishop score

    Time frame: At 41 weeks of amenorrhea

    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)

  2. Bishop score

    Time frame: 3 days after the term of pregnancy

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

  3. Bishop score

    Time frame: 5 days after the term of pregnancy

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

Secondary outcomes

  1. Rate spontaneous labour

    Time frame: At 41 weeks 5 days of amenorrhea

    comparison of spontaneous labour's number in the two groups between 41 weeks of amenorrhea and 41 weeks of amenorrhea and five days.

  2. Duration labor

    Time frame: At 41 weeks 5 days of amenorrhea

    comparison of average number of hours between entry into the delivery room and the delivery, in the two groups.

  3. Rate of delivery with medical intervention

    Time frame: At 41 weeks 5 days of amenorrhea

    comparison medical intervention's number in the two groups.

  4. Rate of delivery by cesarean

    Time frame: At 41 weeks 5 days of amenorrhea

    comparison cesarean's number in the two groups

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: MATUPUNCTURE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.