PROM (Pregnancy), Induced; Birth, Acupuncture, Labour, Cervical Ripening
Conditions
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.
Interventions
DEVICEAcupuncture needles
See arm description
Sponsors
Prof. Fabio Facchinetti
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of spontaneous onset of labour and avoidance of labour induction after 24 hours from PROM | Time between PROM and birth/delivery |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Other
| Measure | Time frame |
|---|---|
| Time elapsed between PROM and full dilation | Time elapsed between PROM and full dilation (10 cm) |
Countries
Italy
Outcome results
None listed