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

Overview

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.

Full Title of Study: “Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2016

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Endometritis rate
    • Time Frame: 3 years

Secondary Measures

  • Puerperal fever
    • Time Frame: 3 years

Participating in This Clinical Trial

Inclusion Criteria

  • suspected retained placenta Exclusion Criteria:

  • Intrapartum fever

Gender Eligibility: Female

Minimum Age: 15 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hadassah Medical Organization
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Hadas Lamnerg, MD, : 00 972 2 6777572, lhadas@hadassah.org.il

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