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

Not Applicable

Completed

• Conditions: PROM (Pregnancy); Induced; Birth; Acupuncture; Labour; Cervical Ripening
• Interventions: Device: Acupuncture needles

• Registration Number: NCT06623175
• Lead Sponsor: Prof. Fabio Facchinetti

Brief 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. Secondary outcomes were considered the duration of first and second stage of labour, the time elapsed between PROM and delivery.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-05
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Study First Submitted: 2024-09-24
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture group	Acupuncture needles	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.

Primary Outcome Measures

Name	Time	Method
Rate of spontaneous onset of labour and avoidance of labour induction after 24 hours from PROM	Time between PROM and birth/delivery

Secondary Outcome Measures

Name	Time	Method
Duration of second stage of labour	Time between established labour and delivery
Time elapsed between PROM and delivery	Time elapsed between PROM and delivery
Duration of first stage of labour	Time between PROM and active labour

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria di Modena; 🇮🇹 Modena, Italy