EFFECT OF ANTIBIOTICS IN PREGNANT MOTHERS ON THE MOTHER AND NEWBORN INFANT
Phase 3
- Conditions
- Health Condition 1: null- Mothers who fulfilled the inclusion criteria were randomised in the trial and their babies were recruited in the study.
- Registration Number
- CTRI/2016/03/006710
- Lead Sponsor
- INSTITUTION RESEARCH COMMITTEE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 1200
Inclusion Criteria
Once mother who met the inclusion criteria was posted for cesarean section she was randomized in the trial.Both mothers and babies were seen for complications till discharge and thereafter at 45 days of life when they come for their immunisation
Exclusion Criteria
Mother
1. Mothers with known allergy to Cephalosporin / Penicillin.
2. Mothers who have received antibiotics within a week prior to the delivery.
3. Mothers with altered liver function (serum total bilirubin >3mg/dL).
4. Mother with renal dysfunction (serum creatinine >1.5mg/dL).
5. Mothers on medications such as carbamazepine or phenytoin.
6. Unable to take consent due to emergency CS.
Neonate
1. Babies born at <37 weeksâ?? gestational age
2. Babies with major congenital anomalies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome: <br/ ><br>A. Maternal outcome <br/ ><br>1) Surgical site infections until 6 weeks post operative <br/ ><br>2) Endometritis until 6 weeks post operative <br/ ><br>3) Urinary tract infection until 6 weeks post operative <br/ ><br> 4) Length of hospital stay <br/ ><br> <br/ ><br>B. Neonatal Outcome <br/ ><br>1.) Incidence of septicemia <br/ ><br>2.) Oral thrush <br/ ><br>3.) Increased frequency of stools <br/ ><br>4.) Development of necrotizing enterocolitis <br/ ><br>5.) Length of hospital stay <br/ ><br> <br/ ><br>Timepoint: Both babies and mothers were seen during the hospital stay from day 1 of surgery till discharge form the hospital
- Secondary Outcome Measures
Name Time Method A. Maternal Outcome <br/ ><br>1.) Number of readmissions in hospital (until 6 weeks post partum) <br/ ><br>2.) Maternal death due to sepsis or other causes up to 6 weeks postpartum <br/ ><br> <br/ ><br>B. Neonatal outcome <br/ ><br>1.) Re-admissions in hospital (CMCH or elsewhere) until 6 weeks of age <br/ ><br>2.) Mortality within first 6 weeks of life <br/ ><br>Timepoint: Both babies and mothers were seen after discharge till about 45 days after birth ( when the babies come for their first immunisation)