Pregnancy Beyond 41 Week's GestationMATUPUNCTURENCT04744168
Acupuncture Effect on the Rate of Maturation in Post Term Pregnancies.
A study testing Acupuncture in people with Pregnancy Beyond 41 Week's Gestation, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Beyond 41 Week's Gestation
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2021to 16 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- Minor patients
- Patients who benefited acupuncture during pregnancy ,
- Imprecise term of delivery,
- Podalic presentation
- Patients under supervision or curatorship,
- Patients without social security.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pregnancy Beyond 41 Week's Gestation
- Being tested
- Acupuncture, Placebo Acupuncture
- Keywords
- Bishop's score, Maturation, Acupuncture, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Puncture of 5 points 4GI, 6RP, 34VB, 36E, 3F
Placebo AcupunctureOther
Puncture of point HM
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 5 days after the term of pregnancy
Secondary outcomes (4)
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.
Measured: 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.
Measured: At 41 weeks 5 days of amenorrhea
Rate of delivery with medical intervention
comparison medical intervention's number in the two groups.
Measured: At 41 weeks 5 days of amenorrhea
Rate of delivery by cesarean
comparison cesarean's number in the two groups
Measured: At 41 weeks 5 days of amenorrhea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start9 Mar 2021
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Beyond 41 Week's GestationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744168
- Sponsor's protocol ID
- 2020-A03023-36
- Acronym
- MATUPUNCTURE
- Status last verified
- May 2026
- First submitted
- 22 Jan 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Effect on the Rate of Maturation in Post Term Pregnancies.
- ClinicalTrials.gov ID
- NCT04744168
- Acronym / sponsor ID
- MATUPUNCTURE / 2020-A03023-36
- Conditions
- Pregnancy Beyond 41 Week's Gestation
- Keywords
- Bishop's score, Maturation, Acupuncture, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureIn 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. |
| Placebo acupuncture | Placebo comparator | Other: Placebo AcupunctureIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Nulliparous or multipares with physiological pregnancy at 41 weeks
- Cephalic foetal presentation,
- Healthy or unicicatricial uterus,
- Major patientes,
- Speaking french,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupuncturePuncture of 5 points 4GI, 6RP, 34VB, 36E, 3F | Other | Acupuncture |
| Placebo AcupuncturePuncture of point HM | Other | Placebo acupuncture |
Primary outcome
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)
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
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
4 secondary outcomes
Rate spontaneous labour
Time frame: At 41 weeks 5 days of amenorrhea
Duration labor
Time frame: At 41 weeks 5 days of amenorrhea
Rate of delivery with medical intervention
Time frame: At 41 weeks 5 days of amenorrhea
Rate of delivery by cesarean
Time frame: At 41 weeks 5 days of amenorrhea
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Pregnancy Beyond 41 Week's Gestation, run by Centre Hospitalier Sud Francilien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bishop score (time frame: At 41 weeks of amenorrhea). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.