NCT06572761

A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Previable Labour With Intact Membranes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2024-08-27
• Last updated: 2024-08-27

Locations

1 site across 1 country: France