Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572761
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECHEC-MAT
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
Detailed Description:
Observational data suggest that subclinical infectious conditions can lead to spontaneous preterm labor 10 of births are premature but the morbiditymortality of premature babies is concentrated mainly among newborns born before 30 weeks of gestation or weighing less than 1500 g The relationship to infectioninflammation 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 morbiditymortality 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 investigators 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
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 morbiditymortality 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 investigators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None