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Completed

NCT Number: NCT06623175

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

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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Key information

Conditions

PROM (Pregnancy) Acupuncture Cervical Ripening Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Induced; Birth Labour Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture needles

Device

See arm description

Primary outcomes

  1. Rate of spontaneous onset of labour and avoidance of labour induction after 24 hours from PROM

    Time frame: Time between PROM and birth/delivery

Secondary outcomes

  1. Duration of second stage of labour

    Time frame: Time between established labour and delivery

  2. Time elapsed between PROM and delivery

    Time frame: Time elapsed between PROM and delivery

  3. Duration of first stage of labour

    Time frame: Time between PROM and active labour

Other outcomes

  1. Time elapsed between PROM and full dilation

    Time frame: Time elapsed between PROM and full dilation (10 cm)

Sponsors and collaborators

Lead sponsor

Prof. Fabio Facchinetti

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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