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

NCT01945450 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-11-27

No results posted yet for this study

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.

Conditions

  • Endometritis

Interventions

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

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-09-30

Countries

  • Israel

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01945450 on ClinicalTrials.gov