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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-05

Study Completion Date

2023-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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PROM (Pregnancy) Induced; Birth Acupuncture Labour Cervical Ripening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Acupuncture needles

Intervention Type DEVICE

See arm description

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture needles

See arm description

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No