| CTRI Number |
CTRI/2025/11/097347 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of recovery between patient following enhanced recovery after caesarian delivery and patient treated with normal post caesarian section recovery protocol |
|
Scientific Title of Study
|
Maternal Outcomes Following Elective Caesarean Section:A Randomized Controlled Trial Of ERAS versus Conventional care |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Varshini |
| Designation |
OBG PG |
| Affiliation |
JNMC, KLE |
| Address |
JNMC KLE University campus
OBG department,G-1 Labour room Nehru Nagar, Belagavi, Karnataka
JNMC KLE University campus
OBG department, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9849544066 |
| Fax |
|
| Email |
varshinitpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anira Dalal |
| Designation |
OBG Professor |
| Affiliation |
JNMC, KLE |
| Address |
JNMC KLE University campus
OBG department, G-1 Labour room Nehru Nagar, Belagavi, Karnataka
JNMC KLE University campus
OBG department, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9448140343 |
| Fax |
|
| Email |
anitamgan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Varshini |
| Designation |
OBG PG |
| Affiliation |
JNMC, KLE |
| Address |
JNMC KLE University campus
OBG department, G-1 Labour room, Nehru Nagar, Belagavi, Karnataka
JNMC KLE University campus
OBG department, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9849544066 |
| Fax |
|
| Email |
varshinitpt@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
K Varshini |
| Address |
JNMC KLE University campus
OBG department, G-1 Labour room, Nehru Nagar, Belagavi, Karnataka
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Varshini |
Dr KLEs Prabhakar Kore Hospital |
Department of obstetrics and gynaecology
KLES Dr Prabhakar Kore hospital and medical research centre
Belgaum
KARNATAKA |
09849544066
varshinitpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare, (2) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional arm |
Foley’s catheter removed within 24-48 hours of surgery, injectable antibiotics and analgesics continued for 48 hours postoperatively followed by five days oral antibiotics. |
| Comparator Agent |
Enhanced recovery after surgery protocol following elective c section |
1.pre anesthetic check-up done.
2.patient counselled on ERAS and expectations.
3.pre-op antibiotics given within 60 mins
before uterine incision.
4.Normothermia maintained during intraoperatively.
5.Redosing of antibiotics intraoperatively if surgery is prolonged/blood loss is significant.
6.Sips of water less than 2 hours post operatively, oral feeding in less than 8 hours.
7.Early ambulation (within 6-12 hours).
8.Intravenous fluids to stop within 12 hours postoperatively.
9.Urinary catheter removed within 8-12 hours.
10.Breast feeding initiated early within 1-2 hours.
11.Discharge criteria to be met within 48-72 hours.
12.Injectable antibiotics for 24 hours followed by oral antibiotics for 5 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.singleton pregnancy
2.18-45 years of age group
3.more than 28 weeks gestation |
|
| ExclusionCriteria |
| Details |
1.Women undergoing emergency cesarean delivery
2.Hypertensive disorders of pregnancy
3.Cardiac diseases, pulmonary diseases
4.Chronic renal diseases
5.Women diagnosed with antepartum hemorrhage Placenta previa, Placenta accreta spectrum
6.Nonconsenting women
7.Patients with hemorrhagic diathesis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary objective: To assess the effectiveness of the ERAS protocol in reducing post operative recovery time (measured by time to mobilization, time to oral intake, and length of hospital stay) following elective cesarean delivery |
More than 28 weeks period of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objectives:
1.To compare the postoperative pain scores (using standardized pain scales such as VAS) between ERAS & standard care groups
2.To evaluate maternal satisfaction with postoperative care
3.To assess the incidence of postoperative complications, including nausea, vomiting, wound infection, & bleeding
|
More than 28 weeks period of gestation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Introduction- Enhanced recovery after surgery protocol is a multidisciplinary patient care model, based on evidence-based protocols with an aim to reduce surgical stress response and thereby improve post operative outcome (1) these guidelines were designed for patients who undergo different surgical procedures. Improved recovery has as its central philosophy to reduce the harmful effects of surgery. This allows a rapid and beneficial postsurgical recovery (2). The most important aspects of this approach are adequate postoperative nutrition, a reduction in surgical stress response, minimum use of opioids in postsurgical analgesia, early mobilization, application of postoperative care designed and managed by multidisciplinary team (3) Cesarean section is one of the most practiced surgeries in the world. There are increased risks for both mother and child compared to vaginal delivery, with a 2-fold increase in maternal morbidity compared with vaginal delivery(4).The basic principle of ERAS includes preoperative counselling, fluid balance, regional anesthetic and non- opioid analgesic consideration, early ambulation, early initiation of breast feeding (5). Early dressing, chewing gum every 8 hrs. Need for study- Cesarean section is one of the most practiced surgeries in the world. Globally, the average cesarean section rate has been increased steadily, with a current rate around 21%,with some large variations between regions(6) The goal is to assess the effectiveness and practicability of using ERAS protocol in surgical management of women undergoing elective caesarean deliveries at a tertiary care hospital and to ascertain its effect on outcomes like length of hospital stay, resumption of bladder or bladder habits, post operative complications and quality of life. Data collection procedure - During the study period of 12 months, 100 women undergoing elective caesarean delivery will be assessed for eligibility. Those who do not meet the eligibility criteria will be excluded. Finally women will be randomized in 1: 1 allocation into ERAS and Conventional arm (50 in each group). There will be no protocol deviations or lost to follow up in each arm. Both arms will be similar in baseline and clinical characteristics. RANDOMIZATION METHOD USED :(SNOSE) Sequentially numbered, opaque, sealed envelope technique- 1. Opaque, sequentially numbered envelopes are used which are numbered in advance (1,2,3,..) 2. Randomization list: Master list of treatment assignments in random order (generated by computer) 3. Each card indicates the assigned arm (ERAS protocol vs standard care) in 1:1 ratio 4. Cards folded and placed inside envelopes matching the sequence 5. Prior to elective cesarean section, each eligible participant who has provided with informed consent will be assigned these envelopes 6. Sequentially numbered opaque envelopes will be opened in front of participant and assignment will be revealed and recorded.
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