Extra Hospital Delivery Outside Medical Presence.

NCT03364517 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8208

Last updated 2024-09-19

No results posted yet for this study

Summary

The purpose of this study is to prospectively evaluate a standardized procedure of medical regulation based on a validated predictive score of eminent delivery (SPIA) in comparison with usual inhomogeneous practices. This standardized procedure impacting the process of care production (when receiving the call for regulation for unannounced delivery) would improve the quality of care of parturients while rationalizing the use of medical teams in the field.

Conditions

  • Delivery

Interventions

OTHER

Predictor score of the imminence of a childbirth (SPIA)

The SPIA score is based on the analysis of 6 types of criteria: panic during the call, the possibility of having a telephone contact with the parturient, the urge to push and if so for how long, the rhythm of the CU, some aggravating factors (history of fast delivery or at home, maternal age between 26 and 35 years, lack of follow-up of pregnancy) and 2 minor factors (nulliparity and the taking of a tocolytic treatment). Each criteria is between 0 to 8, except for the 2 minor criteria for which 7 and 3 points are removed if they are present. This gives a score between -10 and +33, which is weighted according to the admission time estimated at the hospital (30 minutes, 1h and 2h).

Sponsors & Collaborators

  • Hôpital NOVO

    lead OTHER

Principal Investigators

  • Agnès RICARD-HIBON · Hôpital NOVO

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2021-12-14
Completion
2021-12-14

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03364517 on ClinicalTrials.gov