Effects of Acupuncture in Spontaneous Rapture of Membranes: Applicability and Effectiveness

October 1, 2024 updated by: Prof. Fabio Facchinetti
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy
        • Azienda Ospedaliero-Universitaria di Modena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture group
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.
Device: Acupuncture needles
See arm description
No Intervention: Non acupuncture group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of spontaneous onset of labour and avoidance of labour induction after 24 hours from PROM
Time Frame: Time between PROM and birth/delivery
Time between PROM and birth/delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of second stage of labour
Time Frame: Time between established labour and delivery
Time between established labour and delivery
Time elapsed between PROM and delivery
Time Frame: Time elapsed between PROM and delivery
Time elapsed between PROM and delivery
Duration of first stage of labour
Time Frame: Time between PROM and active labour
Time between PROM and active labour

Other Outcome Measures

Outcome Measure
Time Frame
Time elapsed between PROM and full dilation
Time Frame: Time elapsed between PROM and full dilation (10 cm)
Time elapsed between PROM and full dilation (10 cm)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Fabio Facchinetti

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2018

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 126/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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