PROM (Pregnancy)NCT06623175
Effects of Acupuncture in Spontaneous Rapture of Membranes: Applicability and Effectiveness
A study testing Acupuncture needles in people with PROM (Pregnancy) and Induced; Birth, run by Prof. Fabio Facchinetti at 1 site in Italy.
Trial summary
The aim of the study is to investigate the effects of acupuncture in women presenting with spontaneous rapture of membranes (PROM) at term and negative swab for Streptococcus Agalactie to promote a spontaneous onset of labour and avoid labour induction after 24 hours, accordingly to our policy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- PROM (Pregnancy), Induced; Birth, Acupuncture
- What is being tested?
- Acupuncture needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jul 2018to 1 Oct 2023
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PROM after 37 weeks of gestation
- absence of maternal and fetal complications
- negative swab of Streptococcus Agalactiae
- limpid amniotic fluid
- absence of uterine contractions after 6 hours of observation
- single pregnancy
Who cannot join
- PROM before 37 weeks of gestation
- presence of maternal and fetal complications
- positive swab of GBS
- M1 - M3 amniotic fluid
- regular uterine contractions during the first 6 hours of observation
- twin pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the effects of acupuncture in women presenting with spontaneous rapture of membranes (PROM) at term and negative swab for Streptococcus Agalactie to promote a spontaneous onset of labour and avoid labour induction after 24 hours, accordingly to our policy. Secondary outcomes were considered the duration of first and second stage of labour, the time elapsed between PROM and delivery.
- Conditions
- PROM (Pregnancy), Induced; Birth, Acupuncture, Labour, Cervical Ripening
- Being tested
- Acupuncture needles
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture needlesDevice
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | This group of patients were randomly assigned to receive acupuncture in the first 24h after PROM, consisting in the insertion of sterile disposable acupuncture needles, stimulating specific acupoints able to enhance uterine activity, ripe the cervix and reduce anxiety. Receives: Device: Acupuncture needles |
| Non acupuncture group | No intervention | This group of patients were randomly assigned to the no acupuncture group, meaning they received no intervention in the first 24h after PROM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of spontaneous onset of labour and avoidance of labour induction after 24 hours from PROM
Measured: Time between PROM and birth/delivery
Secondary outcomes (3)
Duration of second stage of labour
Measured: Time between established labour and delivery
Time elapsed between PROM and delivery
Measured: Time elapsed between PROM and delivery
Duration of first stage of labour
Measured: Time between PROM and active labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start5 Jul 2018
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROM (Pregnancy)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Fabio Facchinetti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Fabio Facchinetti, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623175
- Sponsor's protocol ID
- 126/2018
- Status last verified
- Oct 2024
- First submitted
- 24 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acupuncture in Spontaneous Rapture of Membranes: Applicability and Effectiveness
- ClinicalTrials.gov ID
- NCT06623175
- Acronym / sponsor ID
- 126/2018
- Conditions
- PROM (Pregnancy), Induced; Birth, Acupuncture, Labour, Cervical Ripening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Prof. Fabio FacchinettiUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 2 Oct 2024 (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.
The aim of the study is to investigate the effects of acupuncture in women presenting with spontaneous rapture of membranes (PROM) at term and negative swab for Streptococcus Agalactie to promote a spontaneous onset of labour and avoid labour induction after 24 hours, accordingly to our policy. Secondary outcomes were considered the duration of first and second stage of labour, the time elapsed between PROM and delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Device: Acupuncture needlesThis group of patients were randomly assigned to receive acupuncture in the first 24h after PROM, consisting in the insertion of sterile disposable acupuncture needles, stimulating specific acupoints able to enhance uterine activity, ripe the cervix and reduce anxiety. |
| Non acupuncture group | No intervention | –This group of patients were randomly assigned to the no acupuncture group, meaning they received no intervention in the first 24h after PROM. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- PROM after 37 weeks of gestation
- absence of maternal and fetal complications
- negative swab of Streptococcus Agalactiae
- limpid amniotic fluid
- absence of uterine contractions after 6 hours of observation
Key exclusion criteria (6 listed)
- PROM before 37 weeks of gestation
- presence of maternal and fetal complications
- positive swab of GBS
- M1 - M3 amniotic fluid
- regular uterine contractions during the first 6 hours of observation
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 |
|---|---|---|
| Acupuncture needlesSee arm description | Device | Acupuncture group |
Primary outcome
Rate of spontaneous onset of labour and avoidance of labour induction after 24 hours from PROM
Time frame: Time between PROM and birth/delivery
3 secondary outcomes
Duration of second stage of labour
Time frame: Time between established labour and delivery
Time elapsed between PROM and delivery
Time frame: Time elapsed between PROM and delivery
Duration of first stage of labour
Time frame: Time between PROM and active labour
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 2 Oct 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 needles in people with PROM (Pregnancy) and Induced; Birth, run by Prof. Fabio Facchinetti at 1 site in Italy.
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 6 inclusion and 6 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 2 Oct 2024. 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 Italy. 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. 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?
Rate of spontaneous onset of labour and avoidance of labour induction after 24 hours from PROM (time frame: Time between PROM and birth/delivery). 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 2 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.