Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PHRC 2004/1918 | Other Identifier | DHOS | |
| PHRC 2008/1929 | Other Identifier | DHOS | |
| 2004/0428 | Other Identifier | sponsor |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to reduce the risk of prematurity have not found a statistically significant diminution of risk (<= 32 wks: OR=0.49 [0.05-5.1], < 37 wks: OR=0.83 [0.59-1.17]).A partial explanation of these findings is that some of these treatment were administered vaginally, most often during the second or third trimester
Aim: To reduce the frequency of late abortions and very preterm birth by prescribing clindamycin vs placebo to patients diagnosed with BV before 13 weeks.
Patients diagnosed with BV before 13 weeks will be divided into two groups. They will be defined as at low risk when they have no history of spontaneous preterm delivery or late abortion. Women with such histories will be defined as at high risk.
Low risk patients will be asked to participate in a trial with 3 equal parallel groups, comparing two regimes of clindamycin (one or three 4-day treatments of clindamycin 300 mgx2/d) and placebo.
High-risk patients will be asked to participate in a trial with 2 parallel groups to assess the usefulness of repeating antibiotic treatment monthly by comparing the administration of one 4-day treatment of clindamycin (300 mgx2/d) to three 4-day treatments, one month apart.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin Cure 1 | Active Comparator | Arm 1 |
|
| Clindamycin Cure 2 | Active Comparator | Arm 2 |
|
| Placebo | Placebo Comparator | Arm placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin | Drug | 300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Premature delivery (16 to 32 weeks of gestation) | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm labor, PPROM, Spontaneous preterm labor, PROM, Abruptio placentae, Chorioamnionitis, Fever > 38°C during labor, Post partum fever (> 38°), Post-partum wound infections, Perinatal death, NICU transfer, Bacterial neonatal colonisation. | At delivery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Damien SUBTIL, MD PhD | University Hospital, Lille (France) | Principal Investigator |
| Gilles Brabant, MD | Groupe Hospitalier de l' Institut Catholique, Lille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Jeanne de Flandre | Lille | 59 000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30322724 | Result | Subtil D, Brabant G, Tilloy E, Devos P, Canis F, Fruchart A, Bissinger MC, Dugimont JC, Nolf C, Hacot C, Gautier S, Chantrel J, Jousse M, Desseauve D, Plennevaux JL, Delaeter C, Deghilage S, Personne A, Joyez E, Guinard E, Kipnis E, Faure K, Grandbastien B, Ancel PY, Goffinet F, Dessein R. Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial. Lancet. 2018 Nov 17;392(10160):2171-2179. doi: 10.1016/S0140-6736(18)31617-9. Epub 2018 Oct 12. |
| Label | URL |
|---|---|
| Website of the study (for patients and all kinds of public) | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart |
|
|
| Clindamycin | Drug | 300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: one time and then, after one month placebo capsules 2 capsules/d during 4 days: two times a month apart |
|
|
| D000091642 | Urogenital Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |