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A Randomized Controlled Trial on the Effectiveness of a Modified Enhanced Recovery After Surgery Protocol (mERAS) in Reducing Surgical Site Infection Following Emergency Cesarean Delivery.

Effectiveness of a Modified Enhanced Recovery After Surgery (mERAS) Protocol in Reducing Surgical Site Infection After Emergency Cesarean Delivery: A Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101348
Enrollment
400
Registered
2026-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication Health Condition 2: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: Modified ERAS Protocol for Emergency Cesarean: Preoperative Minimal preoperative fasting allowed as per safety (e.g. clear fluids up to 2 h, solids 6 h when feasible in emergency contex

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women undergoing emergency cesarean delivery (any indication). Willing to provide informed consent and comply with follow-up (up to 30 days post- surgery).

Exclusion criteria

Exclusion criteria: Elective cesarean deliveries. Known immunocompromised state (e.g. HIV with low CD4, long-term steroids, chemotherapy). Severe comorbidities (e.g., uncontrolled diabetes, severe anaemia, chronic kidney or chronic liver disease, ICU admissions). Pre-existing infection at or near the proposed incision site. Ongoing systemic antibiotic therapy for other infections at the time of surgery (beyond routine prophylaxis). Refusal to participate or inability to follow up (e.g. no reachable contact).

Design outcomes

Primary

MeasureTime frame
Incidence of Surgical Site Infection (SSI) as per CDC criteria within 4 weeks of emergency cesarean delivery, defined as per CDC criteria (superficial, deep, or organ/space SSI).Timepoint: Incidence of Surgical Site Infection (SSI) within 4 weeks of emergency cesarean delivery, defined as per CDC criteria (superficial, deep, or organ/space SSI).—

Secondary

MeasureTime frame
Time to first ambulation (hours after surgery).Timepoint: 6-24 hours;Time to return of bowel function (time to first flatus and/or first bowel movement).Timepoint: 6-24 hours;Postoperative pain scoresTimepoint: 6,24 and 48 hours;Duration of postoperative hospital stay (in days).Timepoint: 3-7 days;Patient satisfaction with perioperative care, measured at discharge using a structured, validated satisfaction questionnaire (e.g. Likert scale).Timepoint: 3-7 days—

Countries

India

Contacts

Public ContactDr Vibha Rani Pipal

All India Institute of Medical Sciences

vibha2005kgmu@gmail.com9799745624

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026