Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-05-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Antibiotics Causing Adverse Effects in Therapeutic Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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group(1)

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

Group Type ACTIVE_COMPARATOR

Group 1: Antibiotic receiving group

Intervention Type 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

Group (2)

69 patients receiving placebo

Group Type PLACEBO_COMPARATOR

Group 1: Antibiotic receiving group

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Group 2 :placebo receiving group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes