NCT02598323

Brief Summary

State of the question and research objective: International trials have shown that ultrasound measurement of the cervix identifies a population at high risk of preterm delivery. In case of short neck several types of treatments can be recommended: progesterone, the establishment of a strapping or pessary. These three treatments reduce the risk of preterm delivery. There is no French study. The objective of this study is to reduce prematurity in the PACA region Monaco-Corsica by introducing a routine ultrasound screening strategy asymptomatic short necks. Population concerned: All patients with active singleton pregnancy between 16 and 26 SA SA are eligible to ultrasound of the cervix.

  • Primary endpoint: delivery rate before 37 weeks.
  • Criteria secondary judgments rate of deliveries before 37 weeks, neonatal mortality morbidity. Expected result: a prematurity of 50%

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

November 4, 2015

Last Update Submit

November 4, 2015

Conditions

Premature Labour

Outcome Measures

Primary Outcomes (1)

  • delivery rate before 37 weeks

    21 weeks maximum

Secondary Outcomes (3)

  • neonatal mortality

    about 30 weeks

  • rate of newborns admitted to intensive care in the first month of life

    about 30 weeks

  • length of stay in intensive care

    about 30 weeks

Study Arms (1)

patients with active singleton pregnancy between 16 and 26 SA

EXPERIMENTAL
Device: ultrasound

Interventions

ultrasoundDEVICE
patients with active singleton pregnancy between 16 and 26 SA

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\> 18 years,
  • pregnancy with single fetus,
  • gestational age between 16SA and 26SA,
  • asymptomatic patients, that is to say, without sign of preterm labor layout

You may not qualify if:

  • Maternal Pathology (Pre Eclampsia, non-insulin dependent diabetes, insulin dependent gestational diabetes or unbalanced)
  • uterine malformation
  • fetal malformation or fetal chromosomal abnormality
  • premature Work in Progress (cervix dilated to more than 2 cm or regular uterine contractions and felt)
  • Signs of chorioamnionitis
  • Allergy to progesterone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HM

Marseille, France

Location

Related Publications (1)

  • Figarella A, Chau C, Loundou A, d'Ercole C, Bretelle F. The introduction of a universal transvaginal cervical length screening program is associated with a reduced preterm birth rate. Am J Obstet Gynecol. 2023 Feb;228(2):219.e1-219.e14. doi: 10.1016/j.ajog.2022.07.046. Epub 2022 Aug 4.

    PMID: 35932876DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Urielle Desalbres

    AP-HM

    STUDY DIRECTOR

Central Study Contacts

Cecile CHAU, MD

CONTACT

cecile.chau@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 5, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2018

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

FR(1)