Clinical Trials Logo
  1. Home
  2. Endometritis
  3. NCT01945450
  4. Details
NCT01945450 Clinical Trial

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

Endometritis Clinical Trial

Official title:
Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01945450
Other study ID # 0186-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 15, 2013
Last updated November 26, 2013
Start date January 2014

Study information
Verified date August 2013
Source Hadassah Medical Organization
Contact Hadas Lamnerg, MD
Phone : 00 972 2 6777572
Email lhadas@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 50 Years
Eligibility Inclusion Criteria:

- suspected retained placenta

Exclusion Criteria:

- Intrapartum fever

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

• Gentamycin

• Clindamycin

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endometritis rate 3 years No
Secondary Puerperal fever 3 years No
See also
  Status Clinical Trial Phase
Recruiting NCT05049395 - HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol N/A
Terminated NCT00386477 - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial N/A
Terminated NCT04163679 - Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections N/A
Recruiting NCT03960970 - Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries Phase 2
Completed NCT03459599 - Antibiotic Prophylaxis in Ragged Placental Membranes N/A
Withdrawn NCT01721616 - Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis Phase 4
Completed NCT01762098 - Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization N/A
Completed NCT01464840 - The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery N/A
Completed NCT01235546 - Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection N/A
Recruiting NCT04307069 - Management of Prelabor Rupture of the Membranes at Term N/A
Terminated NCT01587495 - Pharmacokinetics and Safety of Ertapenem in the Postpartum Period Phase 1
Completed NCT03442218 - Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section N/A
Completed NCT00547170 - Doxycycline Prophylaxis at Vacuum Aspiration Trial Phase 4
Completed NCT00501033 - A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter N/A
Completed NCT00500019 - Uterine Flora During Elective and Urgent Cesarean Sections N/A
Completed NCT00330278 - Timing of Prophylactic Antibiotics for Cesarean Sections N/A
Completed NCT00603603 - Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious Morbidity N/A
Completed NCT00858832 - Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine N/A
Recruiting NCT04197167 - Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis N/A
Completed NCT02402907 - STRIPES Study: Study To Reduce Infection Post cEsarean Section N/A