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

Prof. Fabio Facchinetti

Status: Completed

Conditions: Induced; Birth; Cervical Ripening; Acupuncture; Labour; PROM (Pregnancy)

Treatments: Device: Acupuncture needles

Study type: Interventional

Funder types: Other

Identifiers

NCT06623175

126/2018

Details and patient eligibility

About

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.

Enrollment: 131 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 2 patient groups

Acupuncture group

Experimental group

Description:

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.

Treatment:

Device: Acupuncture needles

Non acupuncture group

No Intervention group

Description:

This group of patients were randomly assigned to the no acupuncture group, meaning they received no intervention in the first 24h after PROM.