Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial
Overview
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.
Full Title of Study: “Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2016
Interventions
- Drug: Antibiotic prophylaxis
- antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3
- Drug: Ampicillin
- Drug: Gentamycin
- Drug: Clindamycin
Arms, Groups and Cohorts
- Active Comparator: Antibiotic prophylaxis
- antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3
- No Intervention: No treatment
- No antibiotics
Clinical Trial Outcome Measures
Primary Measures
- Endometritis rate
- Time Frame: 3 years
Secondary Measures
- Puerperal fever
- Time Frame: 3 years
Participating in This Clinical Trial
Inclusion Criteria
- suspected retained placenta Exclusion Criteria:
- Intrapartum fever
Gender Eligibility: Female
Minimum Age: 15 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Hadassah Medical Organization
- Provider of Information About this Clinical Study
- Sponsor
- Overall Contact(s)
- Hadas Lamnerg, MD, : 00 972 2 6777572, lhadas@hadassah.org.il
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