A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combination of antibiotics, Emergency cerclage, Vaginal progesterone.
- Who it may be relevant to
- Registry conditions: Previable Labour With Intact Membranes. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Combination of Antibiotics to Decrease Neonatal Mortality and Morbidity for Pregnancies Complicated With Previable Labour and Intact Membranes: a Multicenter, Open-label, Randomized and Controlled Trial
Overview
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.
Detailed description
Observational data suggest that subclinical infectious conditions can lead to spontaneous preterm labor. 10% of births are premature, but the morbidity/mortality of premature babies is concentrated mainly among newborns born before 30 weeks of gestation or weighing less than 1500 g. The relationship to infection/inflammation and premature birth is not constant throughout pregnancy, but this infectious risk increases the earlier the gestational age of spontaneous labor is (before 30 weeks). The pathogens that have the strongest associations with premature birth are Gardnerella vaginalis, Ureaplasma urealyticum and Mycoplasma hominis, but also Streptococcus B, Escherichia coli, Klebsiella spp, or Haemophilus influenzae.
Antibiotic treatment to treat an intra-amniotic infection is considered ineffective. Indeed, the last randomized trial (Oracle 2, 2001), which studied several antibiotic regimens for threatened premature delivery with intact membranes, did not find a significant reduction in neonatal morbidity/mortality after administration of co-beta-lactam, erythromycin or the combination of both. In addition, this large trial dominates the results of the latest Cochrane meta-analysis which evaluated preventive antibiotic therapy to stop premature labor with intact membranes.
Recently, it has been showed that a new combination of antibiotics (ceftriaxone, clarithromycin and metronidazole) reduced the risk of infection and intra-amniotic inflammation in preterm labor with intact membranes. This retrospective study deserves to be confirmed by a randomized study
The investigator's goal is to study whether a new combination of antibiotics in a very limited population of pregnancies complicated by the threat of late miscarriage would make it possible to prolong pregnancies in order to improve neonatal outcomes.
Interventions
- Drug Combination of antibiotics
Ceftriaxone : 1g/day parenteral clarithromycin 500 mg\*2/day orally metronidazole 500mg\*3/ day orally - Device Emergency cerclage
Emergency cerclage - Drug Vaginal progesterone
Vaginal progesterone
Primary outcome measures
- A perinatal composite outcome [Time frame: Up to 24 weeks]
Secondary outcome measures (3)
- Gestationnal age at delivery [Time frame: 6 months]
- Maternal Morbidty [Time frame: 6 months]
- Bacteriological [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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
- Foetus alive at time of inclusion
- Absence of regular and painful uterine contractions
Exclusion criteria
- 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.)
- Participation in another research (Specify the category: RIPH, EC, IC, etc.) or being in the exclusion period following previous research involving humans, if applicable
- Patient under AME (if no exemption from affiliation)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Centre Hospitalier Poissy-Saint Germain — Poissy
Identifiers
NCT: NCT06572761 · APHP220670 · 2023-505500-37-00