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

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.

Study Overview

• Status: Unknown
• Conditions: Endometritis
• Intervention / Treatment: Drug: Clindamycin; Drug: Antibiotic prophylaxis; Drug: Ampicillin; Drug: Gentamycin

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadas Lamnerg, MD; Phone Number: : 00 972 2 6777572; Email: lhadas@hadassah.org.il

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• suspected retained placenta

Exclusion Criteria:

• Intrapartum fever

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Clindamycin; 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
No Intervention: No treatment; No antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endometritis rate	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Puerperal fever	3 years

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: September 15, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 18, 2013

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Adnexal Diseases; Pregnancy Complications; Placenta Diseases; Pelvic Inflammatory Disease; Endometritis; Placenta, Retained; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Protein Synthesis Inhibitors; Ampicillin; Anti-Bacterial Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Gentamicins
• Other Study ID Numbers: 0186-HMO-CTIL