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Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05040334
Collaborator
(none)
138
Enrollment
1
Location
2
Arms
15.9
Anticipated Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.

Condition or Disease Intervention/Treatment Phase
  • Drug: Group 1: Antibiotic receiving group
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group 1;receiving antibiotic prophylaxis Group 2; Not receiving antibioticsGroup 1;receiving antibiotic prophylaxis Group 2; Not receiving antibiotics
Masking:
Single (Participant)
Masking Description:
138 identical envelops, half of them filled with a label(Group 1) who are the "Prophylactic antibiotic" group with all instruction details, while the other half are labelled (group 2) who are the "Placebo" group with all instruction details. 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 she will be assigned.
Primary Purpose:
Prevention
Official Title:
Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis. [2 weeks from surgery]

      White cell count >12 *10^9 cells / L by CBC

    Secondary Outcome Measures

    1. Change in the risk of severe puerperal sepsis following the surgical procedure [2 weeks from surgery]

      Signs of puerperal sepsis in form of puerperal pyrexia >38 C and/or purulent vaginal discharge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics and Gynecology, Kasr Al-Ainy University Hospital, Cairo University. Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marwa Mohamed Mahmoud Eid, Principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05040334
    Other Study ID Numbers:
    • Cairo University Obygyn
    First Posted:
    Sep 10, 2021
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pelvic Infection
    Pelvic Inflammatory Disease
    Anti-Bacterial Agents

    Study Results

    No Results Posted as of Mar 28, 2022