NCT06572761

Brief Summary

The purpose of this study is to determine whether a combination of antibiotics (cephalosporin 3rd generation, clarithromycin, metronidazole) are effective to prolong pregnancies complicated with previable threatened labour with intact membranes.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
350

participants targeted

Target at P50-P75 for phase_3

Timeline
45mo left

Started Sep 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 23, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
2 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

August 23, 2024

Last Update Submit

April 27, 2026

Conditions

Previable Labour With Intact Membranes

Keywords

previable labourpreterm

Outcome Measures

Primary Outcomes (1)

  • A perinatal composite outcome

    * Late miscarriage * Perinatal mortality * Bronchodysplasia, * Sepsis proven by blood culture, * Intraventricular hemorrhage ≥3, * Periventricular leukomalacia ≥2, * Ulcero-necrotizing enterocolitis at stage ≥2 according to the Bell classification.

    Up to 24 weeks

Secondary Outcomes (3)

  • Gestationnal age at delivery

    6 months

  • Maternal Morbidty

    6 months

  • Bacteriological

    6 months

Study Arms (2)

Combination of antibiotics

EXPERIMENTAL

Combination of antibiotics (3rd generation of cephalosporin, clarithromycin, metronidazole) \+ routine care (emergency cerclage, vaginal progesterone)

Drug: Combination of antibioticsDevice: Emergency cerclageDrug: Vaginal progesterone

Routine care

ACTIVE COMPARATOR

Routine care (emergency cerclage, vaginal progesterone)

Device: Emergency cerclageDrug: Vaginal progesterone

Interventions

Combination of antibioticsDRUG

Ceftriaxone : 1g/day parenteral clarithromycin 500 mg\*2/day orally metronidazole 500mg\*3/ day orally

Also known as: Ceftriaxone; clarithromycin, metronidazole
Combination of antibiotics
Emergency cerclageDEVICE

Emergency cerclage

Combination of antibioticsRoutine care
Vaginal progesteroneDRUG

Vaginal progesterone

Combination of antibioticsRoutine care

Eligibility Criteria

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

You may qualify if:

  • Threatened previable prelabor with intact membranes between 18weeks of gestation +0/7 and 23 weeks of gestation 6/7 SA defined on endovaginal ultrasound by a short cervix ≤10 mm, and/or protrusion of the membranes on speculum examination.
  • Maternal age \>18 years
  • Affiliated with social security
  • Correct understanding of the French language
  • Singleton pregnancy
  • Absence of regular and painful uterine contractions

You may not qualify if:

  • Premature labor defined by regular, painful uterine contractions and a short cervix
  • Protected person (patient under guardianship/curatorship/or legal protection)
  • Multiple pregnancies
  • Premature rupture of membranes
  • Acute chorioamnionitis
  • Contraindication to protocol antibiotics
  • Chromosomal abnormality, congenital malformation
  • Patients who received antibiotics before randomization, or requiring antibiotics for another indication (chorioamnionitis, pyelonephritis, etc.)
  • Patient under AME (if no exemption from affiliation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Poissy-Saint Germain

Poissy, 78300, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

CeftriaxoneClarithromycinMetronidazole

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Thibaud QUIBEL, MD, PhD

    Centre Hospitalier Poissy-Saint Germain

    PRINCIPAL INVESTIGATOR

  • Jean BOUYER

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY CHAIR

Central Study Contacts

Thibaud QUIBEL, MD, PhD

CONTACT

0178636012thibaud.quibel@ght-yvelinesnord.fr

Charly LARRIEU

CONTACT

01 58 41 34 78charly.larrieu@aphp.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 27, 2024

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

FR(1)