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

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ClinicalTrials.gov Identifier: NCT01945450
Recruitment Status : Unknown
Verified August 2013 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : September 18, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Study Description
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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.


Condition or disease Intervention/treatment Phase
Endometritis Drug: Antibiotic prophylaxis Drug: Ampicillin Drug: Gentamycin Drug: Clindamycin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth
Study Start Date : January 2014
Estimated Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Antibiotic prophylaxis
antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3
 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
No Intervention: No treatment
No antibiotics


Outcome Measures
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Primary Outcome Measures :
  1. Endometritis rate [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Puerperal fever [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suspected retained placenta

Exclusion Criteria:

  • Intrapartum fever
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945450


Contacts
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Contact: Hadas Lamnerg, MD : 00 972 2 6777572 lhadas@hadassah.org.il

Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
More Information
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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01945450    
Other Study ID Numbers: 0186-HMO-CTIL
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Endometritis
Placenta, Retained
Pelvic Inflammatory Disease
Adnexal Diseases
Uterine Diseases
Placenta Diseases
Pregnancy Complications
Anti-Bacterial Agents
Clindamycin
 Clindamycin palmitate
Clindamycin phosphate
Gentamicins
Ampicillin
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action