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

H

Hadassah Medical Center

Status

Unknown

Conditions

Endometritis

Treatments

Drug: Clindamycin
Drug: Ampicillin
Drug: Antibiotic prophylaxis
Drug: Gentamycin

Study type

Interventional

Funder types

Other

Identifiers

NCT01945450
0186-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Female

Ages

15 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • suspected retained placenta

Exclusion criteria

  • Intrapartum fever

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Antibiotic prophylaxis
Active Comparator group
Description:
antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\*4, Gentamycin 240 mg\*1, Clindamycin 600 mg\*3
Treatment:
Drug: Gentamycin
Drug: Clindamycin
Drug: Antibiotic prophylaxis
Drug: Ampicillin
No treatment
No Intervention group
Description:
No antibiotics

Trial contacts and locations

1

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Central trial contact

Hadas Lamnerg, MD

Data sourced from clinicaltrials.gov

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