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

Primary Purpose

Endometritis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Antibiotic prophylaxis
Ampicillin
Gentamycin
Clindamycin
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometritis

Eligibility Criteria

15 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • suspected retained placenta

Exclusion Criteria:

  • Intrapartum fever

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Antibiotic prophylaxis

No treatment

Arm Description

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

No antibiotics

Outcomes

Primary Outcome Measures

Endometritis rate

Secondary Outcome Measures

Puerperal fever

Full Information

First Posted
September 15, 2013
Last Updated
November 26, 2013
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01945450
Brief Title
Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial
Official Title
Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antibiotic prophylaxis
Arm Type
Active Comparator
Arm Description
antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No antibiotics
Intervention Type
Drug
Intervention Name(s)
Antibiotic prophylaxis
Intervention Description
antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3
Intervention Type
Drug
Intervention Name(s)
Ampicillin
Intervention Type
Drug
Intervention Name(s)
Gentamycin
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Primary Outcome Measure Information:
Title
Endometritis rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Puerperal fever
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: suspected retained placenta Exclusion Criteria: Intrapartum fever
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lamnerg, MD
Phone
: 00 972 2 6777572
Email
lhadas@hadassah.org.il
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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