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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505500-37-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of antibiotics | Experimental | Combination of antibiotics (3rd generation of cephalosporin, clarithromycin, metronidazole) + routine care (emergency cerclage, vaginal progesterone) |
|
| Routine care | Active Comparator | Routine care (emergency cerclage, vaginal progesterone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of antibiotics | Drug | Ceftriaxone : 1g/day parenteral clarithromycin 500 mg*2/day orally metronidazole 500mg*3/ day orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| A perinatal composite outcome |
| Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gestationnal age at delivery |
| 6 months |
| Maternal Morbidty |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thibaud QUIBEL, MD, PhD | Contact | 0178636012 | thibaud.quibel@ght-yvelinesnord.fr | |
| Charly LARRIEU | Contact | 01 58 41 34 78 | charly.larrieu@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Poissy-Saint Germain | Poissy | 78300 | France |
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| Emergency cerclage | Device | Emergency cerclage |
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| Vaginal progesterone | Drug | Vaginal progesterone |
|
Chorioamniotitis, postpartum endometritis , sepsis proven par positive hemocultures |
| 6 months |
| Bacteriological | Acquisition of multi-resistant germs during childbirth | 6 months |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| D017291 | Clarithromycin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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