Skip to content

EFFECT OF ANTIBIOTICS IN PREGNANT MOTHERS ON THE MOTHER AND NEWBORN INFANT

EFFECT OF MATERNAL ANTIBIOTICS ON THE MOTHER AND NEWBORN INFANT - EMAMI

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/03/006710
Enrollment
1200
Registered
2016-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Mothers who fulfilled the inclusion criteria were randomised in the trial and their babies were recruited in the study.

Interventions

Intervention1: Women undergoing caesarean section were randomized to receive both single dose of IV Cefazoline and placebo. As per the randomization every mother was given IV Cefazoline either prior t

Sponsors

INSTITUTION RESEARCH COMMITTEE
Lead Sponsor

Eligibility

Inclusion criteria

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

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 2. Babies with major congenital anomalies

Design outcomes

Primary

MeasureTime frame
Primary Outcome: A. Maternal outcome 1) Surgical site infections until 6 weeks post operative 2) Endometritis until 6 weeks post operative 3) Urinary tract infection until 6 weeks post operative 4) Length of hospital stay B. Neonatal Outcome 1.) Incidence of septicemia 2.) Oral thrush 3.) Increased frequency of stools 4.) Development of necrotizing enterocolitis 5.) Length of hospital stay Timepoint: Both babies and mothers were seen during the hospital stay from day 1 of surgery till discharge form the hospital

Secondary

MeasureTime frame
A. Maternal Outcome 1.) Number of readmissions in hospital (until 6 weeks post partum) 2.) Maternal death due to sepsis or other causes up to 6 weeks postpartum B. Neonatal outcome 1.) Re-admissions in hospital (CMCH or elsewhere) until 6 weeks of age 2.) Mortality within first 6 weeks of life Timepoint: Both babies and mothers were seen after discharge till about 45 days after birth ( when the babies come for their first immunisation)

Countries

India

Contacts

Public ContactCHINTA ANNIE JYOTHIRMAYI

CHRISTIAN MEDICAL COLLEGE AND HOSPITAL - VELLORE

rubyjose1@gmail.com0416-2286185

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 26, 2026