A Randomised control trial to look at antibiotic prophylaxis in operative vaginal delivery.

Not yet recruiting

Conditions: Infection of obstetric surgical wound, (2) ICD-10 Condition: O861||Other infection of genital tract following delivery, (3) ICD-10 Condition: O85||Puerperal sepsis, (4) ICD-10 Condition: O864||Pyrexia of unknown origin following delivery, (5) ICD-10 Condition: O862||Urinary tract infection followingdelivery,

Registration Number: CTRI/2022/08/044547

Lead Sponsor: Christian Medical College and Hospital Vellore

Brief Summary: This study aims to look at the use of single dose prophylactic antibiotic in preventing infections in women undergoing operative vaginal deliveries. This study will be a double blinded randomised control trial carried out among women undergoing operative vaginal deliveries. Eligible women will be randomized into interventional arm which will receive a single dose of Amoxycillin clavulanic acid and a placebo arm which will receive normal saline. Primary outcomes studied will include evidence of new onset confirmed or suspected infection within 6 weeks postpartum as evidenced by a new prescription for antibiotic for perineal wound related infection, endometritis, urinary tract infection or sepsis. Secondary outcomes will include perineal pain, health related quality of life, need for hospital visits or readmission and breastfeeding.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 700

Inclusion Criteria

1.Women aged 16 years or above, willing and able to give informed consent.
2.Women who have had an operative vaginal delivery at 36+0 completed weeks or greater gestation.

Exclusion Criteria

1.Clinical indication for continuation of antibiotic administration post-delivery 2.Known allergy to penicillin or to any of the components of co-amoxiclav, as previously identified 3.History of anaphylaxis to another Î²-lactam agent (e.g. cephalosporin, carbapenem or monobactam).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmed or suspected maternal infection	Any time within 6 weeks of delivery

Secondary Outcome Measures

Name	Time	Method
1.Need for additional pain relief	2.Days of hospitalization

Trial Locations

Locations (1): Community Health and Development (CHAD) Hospital
🇮🇳
Vellore, TAMIL NADU, India
Community Health and Development (CHAD) Hospital
🇮🇳Vellore, TAMIL NADU, India
Anne George Cherian
Principal investigator
04162284207
annegc97@yahoo.co.in