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NCT01945450 Clinical Trial

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

Endometritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01945450
Other study ID # 0186-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 15, 2013
Last updated November 26, 2013
Start date January 2014

Study information
Verified date August 2013
Source Hadassah Medical Organization
Contact Hadas Lamnerg, MD
Phone : 00 972 2 6777572
Email lhadas@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 50 Years
Eligibility Inclusion Criteria:

- suspected retained placenta

Exclusion Criteria:

- Intrapartum fever

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Antibiotic prophylaxis
antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3
• Ampicillin

• Gentamycin

• Clindamycin

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endometritis rate 3 years No
Secondary Puerperal fever 3 years No
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