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Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

Primary Purpose

Antibiotics Causing Adverse Effects in Therapeutic Use

Status

Recruiting

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Group 1: Antibiotic receiving group

About this trial

This is an interventional prevention trial for Antibiotics Causing Adverse Effects in Therapeutic Use

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Department of Obstetrics and Gynecology, Kasr Al-Ainy University Hospital, Cairo University.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

group(1)

Group (2)

Arm Description

69 patients receiving a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)tablets

69 patients receiving placebo

Outcomes

Primary Outcome Measures

Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis.

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

Secondary Outcome Measures

Change in the risk of severe puerperal sepsis following the surgical procedure

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

Full Information

NCT ID

NCT05040334

First Posted

August 14, 2021

Last Updated

March 24, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05040334

Brief Title

Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

Official Title

Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

April 1, 2022 (Anticipated)

Study Completion Date

May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Antibiotics Causing Adverse Effects in Therapeutic Use

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Group 1;receiving antibiotic prophylaxis Group 2; Not receiving antibiotics

Masking

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.

Allocation

Randomized

Enrollment

138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group(1)

Arm Type

Active Comparator

Arm Description

69 patients receiving a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)tablets

Arm Title

Group (2)

Arm Type

Placebo Comparator

Arm Description

69 patients receiving placebo

Intervention Type

Drug

Intervention Name(s)

Group 1: Antibiotic receiving group

Other Intervention Name(s)

Group 2 :placebo receiving group

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis.

Description

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

Time Frame

2 weeks from surgery

Secondary Outcome Measure Information:

Title

Change in the risk of severe puerperal sepsis following the surgical procedure

Description

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

Time Frame

2 weeks from surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marwa Mo Eid, Ass.professor

Phone

01001225079

marwameid2014@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Nihal Mo El-Demiry, Lecturer

Phone

01006049052

n.eldemiry@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marwa Mo Eid, Ass.prof.

Organizational Affiliation

Cairo University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Nihal Mo El-Demiry, lecturer

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Obstetrics and Gynecology, Kasr Al-Ainy University Hospital, Cairo University.

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marwa Mo Eid, Ass prof

Phone

01001225079

marwameid2014@gmail.com

First Name & Middle Initial & Last Name & Degree

Nihal Mo El-Demiry, Lecturer

Phone

: 01006049052

n.eldemiry@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

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