NCT01945450

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

Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: Female
• Age: 15 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-09-01
• First posted: 2013-09-18
• Last updated: 2013-11-27

Locations

1 site across 1 country: Israel