drugset / Trial / NCT01945450

Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial

NCT01945450

Unknown 300 enrolled Hadassah Medical Organization
RandomizedParallel-groupOpen-labelTreatment

Summary

Background: There is scarce evidence regarding the necessity of antibiotic prophylaxis in manual revision of the uterus after labor in cases of residual placenta. Methods: a randomized control trial in which parturients for which the placenta was not separated or there is a suspected residual placenta will be divided randomly to two groups: (1) Revision of uterus or Manual lysis without antibiotic prophylaxis; (2) Revision of uterus or Manual lysis with antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\*4, Gentamycin 240 mg\*1, Clindamycin 600 mg\*3. In cases of allergy to Penicillin the antibiotic regimen will be: Gentamycin 240 mg\*1, Clindamycin 600 mg\*3. Outcomes: Puerperal fever, endometritis, length of hospitalization after labor, recurrent hospitalization in the first 2 weeks after discharge.

Timeline

Start
2014-01
Primary completion
2016-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ampicillin Unknown 2 g
Comparator Clindamycin Unknown 600 mg
Comparator Gentamicin Small molecule 240 mg

Indications