Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

NCT05040334 | Unknown Phase 4

• 1 other identifier: Cairo University Obygyn
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antibiotics Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  2 weeks from surgery

Study Arms (2)

group(1)

ACTIVE COMPARATOR

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

Drug: Group 1: Antibiotic receiving group

Group (2)

PLACEBO COMPARATOR

69 patients receiving placebo

Drug: Group 1: Antibiotic receiving group

Interventions

Group 1: Antibiotic receiving group DRUG

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

Also known as: Group 2 :placebo receiving group

Group (2); group(1)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, Egypt

RECRUITING

Study Officials

• Marwa Mo Eid, Ass.prof.

  Cairo University

  STUDY DIRECTOR

• Nihal Mo El-Demiry, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa Mo Eid, Ass.professor

CONTACT

01001225079; marwameid2014@gmail.com

Nihal Mo El-Demiry, Lecturer

CONTACT

01006049052; n.eldemiry@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Group 1;receiving antibiotic prophylaxis Group 2; Not receiving antibiotics

Study Record Dates

• First Submitted: August 14, 2021
• First Posted: September 10, 2021
• Study Start: January 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

EG (1)