Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

Antibiotics Causing Adverse Effects in Therapeutic Use Clinical Trial

Official title:

Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05040334
• Other study ID #: Cairo University Obygyn
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: Marwa Mo Eid, Ass.professor
• Phone: 01001225079
• Email: marwameid2014[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotics Causing Adverse Effects in Therapeutic Use
• Pelvic Inflammatory Disease

Intervention

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

Locations

Country	Name	City	State
Egypt	Department of Obstetrics and Gynecology, Kasr Al-Ainy University Hospital, Cairo University.	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 weeks from surgery
Secondary	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	2 weeks from surgery