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

Not Applicable

• Conditions: Endometritis
• Interventions: Drug: Antibiotic prophylaxis; Drug: Ampicillin; Drug: Gentamycin; Drug: Clindamycin

• Registration Number: NCT01945450
• Lead Sponsor: Hadassah Medical Organization

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 Description

Not available

Study Timeline

• Status Verified: 2013-08
• Study First Submitted: 2013-09-15
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-18
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27
• Study Start: 2014-01
• Primary Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• suspected retained placenta

Exclusion Criteria

• Intrapartum fever

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic prophylaxis	Antibiotic prophylaxis	antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\*4, Gentamycin 240 mg\*1, Clindamycin 600 mg\*3
Antibiotic prophylaxis	Clindamycin	antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\*4, Gentamycin 240 mg\*1, Clindamycin 600 mg\*3
Antibiotic prophylaxis	Ampicillin	antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\*4, Gentamycin 240 mg\*1, Clindamycin 600 mg\*3
Antibiotic prophylaxis	Gentamycin	antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\*4, Gentamycin 240 mg\*1, Clindamycin 600 mg\*3

Primary Outcome Measures

Name	Time	Method
Endometritis rate	3 years

Secondary Outcome Measures

Name	Time	Method
Puerperal fever	3 years

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel