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

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)

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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