NCT06623175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

5.2 years

First QC Date

September 24, 2024

Last Update Submit

October 1, 2024

Conditions

PROM (Pregnancy)Induced; BirthAcupunctureLabourCervical Ripening

Outcome Measures

Primary Outcomes (1)

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

    Time between PROM and birth/delivery

Secondary Outcomes (3)

  • 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 Outcomes (1)

  • Time elapsed between PROM and full dilation

    Time elapsed between PROM and full dilation (10 cm)

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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.

Device: Acupuncture needles

Non acupuncture group

NO INTERVENTION

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

Interventions

Acupuncture needlesDEVICE

See arm description

Acupuncture group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria di Modena

Modena, Modena, Italy

Location

Related Links

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 24, 2024

First Posted

October 2, 2024

Study Start

July 5, 2018

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

October 2, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)