Endometritis | Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial
Endometritis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - suspected retained placenta Exclusion Criteria: - Intrapartum fever
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Antibiotic prophylaxisantibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Antibiotic prophylaxisantibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3
No treatmentNo antibiotics
Start Date: January 2014
Primary Outcome: Endometritis rate
Secondary Outcome: Puerperal fever
Study sponsors, principal investigator, and references
Lead Sponsor: Hadassah Medical Organization