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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth

Brief 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.

Detailed Summary:
Sponsor: Hadassah Medical Organization

Current Primary Outcome: Endometritis rate [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Puerperal fever [ Time Frame: 3 years ]

Original Secondary Outcome: Same as current

Information By: Hadassah Medical Organization

Dates:
Date Received: September 15, 2013
Date Started: January 2014
Date Completion:
Last Updated: November 26, 2013
Last Verified: August 2013