| CTRI Number |
CTRI/2025/07/091407 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two methods of suture repair, exteriorization and in-situ repair, on the mother in a cesarean section |
|
Scientific Title of Study
|
Maternal outcome of insitu epair versus exteriorization of uterine incision during cesarean section. A Randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Silky Dahiwale |
| Designation |
Junior Resident |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Room number 3, third floor, Department of Obstetrics and Gynaecology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
Digdoh Hills, Hingna
Nagpur
MAHARASHTRA
440016
India |
| Phone |
9766581252 |
| Fax |
|
| Email |
silkyd95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Somalwar |
| Designation |
Associate Professor |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Room number 3, third floor, Department of Obstetrics and Gynaecology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
Digdoh Hills, Hingna
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9158920941 |
| Fax |
|
| Email |
somalwar.sa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Somalwar |
| Designation |
Associate Professor |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Room number 3, third floor, Department of Obstetrics and Gynaecology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
Digdoh Hills, Hingna
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9158920941 |
| Fax |
|
| Email |
somalwar.sa@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India- 440019 |
|
|
Primary Sponsor
|
| Name |
Department of Obstetrics and Gynaecology |
| Address |
Room number 3, third floor, Department of Obstetrics and Gynaecology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna, Nagpur, India-440016 |
| Type of Sponsor |
Private medical college |
|
|
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 Silky Dahiwale |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
Room No. 3, 3rd Floor,
Department of Obstetrics and Gynaecology
Nagpur
MAHARASHTRA |
9766581252
silkyd95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Insitu repair |
In-situ uterine repair during cesarean section refers to suturing the uterine incision while the uterus remains inside the abdominal cavity, without exteriorizing it.
A. The points to be noted intraoperatively will be:
1. Changes in pulse and blood pressure.
2. Symptoms like pain, nausea, and vomiting.
3. Need for additional anaesthetic drugs.
4. Assessment of blood loss
B. The points to be noted postoperatively will be:
1. Need for analgesics
2. Return of bowel activity
3. Surgical site infection
4. Hospital stay
5. Day 3 Hemoglobin |
| Comparator Agent |
Uterine Exteriorization |
Exteriorization of the uterus during a Cesarean section involves temporarily bringing the uterus outside of the abdominal cavity to facilitate repair of the uterine incision.
A. The points to be noted intraoperatively will be:
1. Changes in pulse and blood pressure.
2. Symptoms like pain, nausea, and vomiting.
3. Need for additional anaesthetic drugs.
4. Assessment of blood loss
B. The points to be noted postoperatively will be:
1. Need for analgesics
2. Return of bowel activity
3. Surgical site infection
4. Hospital stay
5. Day 3 Hemoglobin |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Antenatal term women undergoing cesarean section. |
|
| ExclusionCriteria |
| Details |
1. Preterm
2. Diagnosed Placenta accreta spectrum |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in pulse and blood pressure |
1. Intraoperative
2. Post-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Symptoms like pain, nausea, and vomiting.
2. Need for additional anaesthetic drugs.
3. Assessment of blood loss
4. Need for analgesics
5. Return of bowel activity
6. Surgical site infection
7. Hospital stay
8. Day 3 Hemoglobin |
1. Intraoperative
2. Post-operative |
|
|
Target Sample Size
|
Total Sample Size="272"
Sample Size from India="272"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/08/2025 |
| 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="2"
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
|
|
Brief Summary
|
Introduction: Different techniques of uterine closure have been practiced in order to reduce morbidity during and after cesarean delivery. The techniques vary depending on both the clinical situation and the preferences of the operator, and mainly due to limited information available concerning the most appropriate surgical technique to adopt. Hence, this study aims to compare the difference between uterine exteriorization versus in situ repair during cesarean section affecting maternal outcome. Methodology: A total of 272 women undergoing cesarean section will be randomized by computer-generated randomization, and a sequentially numbered, sealed opaque envelope method will be used for allocation in this single-blinded parallel-group randomized controlled trial. Group A (experimental group) will be the patients undergoing uterine exteriorization, and Group B (control group) will be the patients undergoing in-situ uterine repair. Result: The intraoperative observation would note and compare changes in vitals (pulse, blood pressure), symptoms like pain, nausea, and vomiting, need for additional anaesthetic drugs, and assessment of blood loss between both groups. Also, the post-operative observation would note and compare the need for analgesics, return of bowel activity, surgical site infection, hospital stay, and hemoglobin on day 3 between both groups. Conclusion: The present study will compare and conclude the effectiveness of uterine exteriorization and in-situ repair of uterine incision on maternal outcome during cesarean section. This will explore the outcome in terms of recovery, hospital stay, bowel activity, need for analgesics, surgical site infection, and level of hemoglobin. |