Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial
Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometritis
Intervention: Antibiotic prophylaxis (Drug); Ampicillin (Drug); Gentamycin (Drug); Clindamycin (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Hadassah Medical Organization Overall contact:
Hadas Lamnerg, MD, Phone: : 00 972 2 6777572, Email: lhadas@hadassah.org.il
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.
Clinical Details
Official title: Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Endometritis rate
Secondary outcome: Puerperal fever
Eligibility
Minimum age: 15 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- suspected retained placenta
Exclusion Criteria:
- Intrapartum fever
Locations and Contacts
Hadas Lamnerg, MD, Phone: : 00 972 2 6777572, Email: lhadas@hadassah.org.il
Hadassah Medical Organization, Jerusalem, Israel; Not yet recruiting
Additional Information
Starting date: January 2014
Last updated: November 26, 2013
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