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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||September 2016|
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*3Drug: Ampicillin Drug: Gentamycin Drug: Clindamycin
No Intervention: No treatment
- Endometritis rate [ Time Frame: 3 years ]
- Puerperal fever [ Time Frame: 3 years ]
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
|Contact: Hadas Lamnerg, MD||: 00 972 2 firstname.lastname@example.org|
|Hadassah Medical Organization||Not yet recruiting|