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

Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01945450
Enrollment
300
Registered
2013-09-18
Start date
2014-01-31
Completion date
Unknown
Last updated
2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometritis

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.

Interventions

DRUGAntibiotic prophylaxis

antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\*4, Gentamycin 240 mg\*1, Clindamycin 600 mg\*3

DRUGAmpicillin
DRUGClindamycin

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* suspected retained placenta

Exclusion criteria

* Intrapartum fever

Design outcomes

Primary

MeasureTime frame
Endometritis rate3 years

Secondary

MeasureTime frame
Puerperal fever3 years

Countries

Israel

Contacts

Primary ContactHadas Lamnerg, MD
lhadas@hadassah.org.il: 00 972 2 6777572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026