Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

March 24, 2022 updated by: Marwa Mohamed Mahmoud Eid, Cairo University
To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomized to receive either prophylactic antibiotic [a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)] or placebo using identical sealed envelopes.Included cases are those with early miscarriage (within the first trimester 12 6/7 weeks of gestation) , missed or incomplete miscarriage, undergoing surgical management will be included in the study.

Technique:

The investigators will prepare 138 identical envelops, half of them filled with a label group(1) who are the group to receive the antibiotic prophylaxis with all instruction details, while the other half filled with a label identifying ( group 2) who are the placebo group. All envelops will be prepared by the investigator and sealed before starting enrollment. After enrollment, each participant will be allowed to choose one envelop to determine to which group the patient will be assigned to.

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Department of Obstetrics and Gynecology, Kasr Al-Ainy University Hospital, Cairo University.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Maternal age :18-35 years
  • Gestational age: up to 12 6/7 weeks of gestation (confirmed by a reliable date for the last menstrual period or /and 1st trimester ultrasound scan).
  • Singleton miscarriage
  • Type of miscarriage: Incomplete or Missed miscarriage
  • Surgical evacuation will be done within 2 weeks of diagnosis of miscarriage .

Exclusion criteria:

  • Maternal age: younger than 18 years
  • Induced miscarriage of pregnancy
  • Septic miscarriage
  • Evidence of infection
  • Morbid obesity (BMI≥40kg/m2)
  • Allergy to prophylactic antibiotics (i.e., doxycycline or metronidazole)
  • Antibiotics use within 7 days before randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group(1)
69 patients receiving a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)tablets
Drug: Group 1: Antibiotic receiving group
Group 1; receiving antibiotic prophylaxis; single dose of oral doxycycline (200 mg) tablet and metronidazole (500 mg) tablet 2 hours before the surgical evacuation Group B ;receiving placebo 2 hours before the surgical evacuation
Other Names:
  • Group 2 :placebo receiving group
Placebo Comparator: Group (2)
69 patients receiving placebo
Drug: Group 1: Antibiotic receiving group
Group 1; receiving antibiotic prophylaxis; single dose of oral doxycycline (200 mg) tablet and metronidazole (500 mg) tablet 2 hours before the surgical evacuation Group B ;receiving placebo 2 hours before the surgical evacuation
Other Names:
  • Group 2 :placebo receiving group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis.
Time Frame: 2 weeks from surgery
White cell count >12 *10^9 cells / L by CBC
2 weeks from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the risk of severe puerperal sepsis following the surgical procedure
Time Frame: 2 weeks from surgery
Signs of puerperal sepsis in form of puerperal pyrexia >38 C and/or purulent vaginal discharge
2 weeks from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Marwa Mo Eid, Ass.prof., Cairo University
  • Principal Investigator: Nihal Mo El-Demiry, lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

August 14, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cairo University Obygyn

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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