| CTRI Number |
CTRI/2024/04/065068 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the healing ratio of different uterine closure techniques after 6 to 12 months of caesarean section |
|
Scientific Title of Study
|
Comparison of uterine closure techniques during caesarean section on isthmocele formation-A Randomized controlled 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 M Pooja lakshmi |
| Designation |
Post graduate |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of Obstetrics and Gynaecology
OPD Room no 68
Sri manakula vinayagar medical college and hospital
madagadipet
kalitheerthalkuppam
Pondicherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8870511590 |
| Fax |
|
| Email |
poojalakshmi156@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G K Poomalar |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of Obstetrics and Gynaecology
OPD Room no 68
Sri manakula vinayagar medical college and hospital
madagadipet
kalitheerthalkuppam
Pondicherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9442044679 |
| Fax |
|
| Email |
poomalarpragash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Pooja lakshmi |
| Designation |
Post graduate |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of Obstetrics and Gynaecology
OPD Room no 68
Sri manakula vinayagar medical college and hospital
madagadipet
kalitheerthalkuppam
Pondicherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8870511590 |
| Fax |
|
| Email |
poojalakshmi156@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College and hospital Puducherry |
|
|
Primary Sponsor
|
| Name |
Sri manakula vinayagar medical college and hospital |
| Address |
Madagadipet
Kalitheerthalkuppam
Puducherry
605107 |
| 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 M Pooja lakshmi |
Sri manakula vinayagar medical college and hospital |
Department of Obstetrics and Gynaecology
OPD room no 68
Madagadipet
Kalitheerthalkuppam
Puducherry
Pondicherry
PONDICHERRY |
8870511590
poojalakshmi156@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri manakula vinayagar medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Babu and Magon technique(Far Far near near continuous technique) |
GROUP C- Babu and Magon technique (FFNN continuous non-locking double-layer method),double layer suturing will be carried out in a single step. Initially, angle stitches will be taken on both ends of the incision line; followed by that, full thickness far far bite excluding decidua will be taken in lower and upper edge of uterine incision at one end (1 cm away from the uterine edge), then near near bites will be taken in same line with needle holder in same direction, taking only superficial myometrium (0.5 cm from the uterine incision edge). Same technique will be continued at the interval of 1 cm till other end of uterine incision. Assistant will be instructed to follow the suture material without leaving loose. This technique involves suturing uterus in two layers in a single continuous fashion |
| Comparator Agent |
Double layer locking uterine closure technique |
GROUP A-Participants with double layer locked suture technique. First layer will include deeper myometrial tissue excluding the decidua with continuous interlocking technique using vicryl no 1. Second layer will be taken with catgut 1-0 non-locking of superficial myometrium.
|
| Comparator Agent |
Double layer unlocking uterine closure technique |
GROUP B-Participants with double layer non-locked suture technique: First layer will include deeper myometrial tissue excluding the decidua with continuous non-locking technique using Vicryl number 1. Second layer will be taken with catgut 1-0 non-locking of superficial myometrium.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
singleton pregnancies undergoing elective and emergency caesarean delivery |
|
| ExclusionCriteria |
| Details |
1.Preterm caesarean section
2.Placenta previa
3.History of scar dehiscence in patients who have undergone caesarean section before
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the uterine closure techniques on isthmocele formation in primary and repeat caesarean section
(Niche length
Niche depth
Residual myometrial thickness Adjacent myometrial thickness) |
After 6-12 months of caesarean section |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of different uterine closure techniques on residual myometrial thickness in primary & repeat caesarean section(Residual myometrial thickness)
To compare the need for additional sutures required between different uterine closure techniques
(Estimated blood loss)
|
After 6-12 months of caeserean section
Immediately after delivery |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="6"
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
|
Caesarean section is increasing worldwide. Current caesarean section rate is 15-20%. As a result of caesarean section, there are chances for suture site weakening. Medical terminology for weakness of scar, resulting in bulge in lower uterus is called as isthmocele or niche. Isthmocele results in menstrual abnormality in inter-delivery period. During pregnancy, it can result in scar thinning out during delivery. Usually uterine closure is done with either single layer or double layer closure technique, single layer uterine closure technique results in slightly higher chance of weakening of scar compared to double layer. Within double layer closure there are different techniques. We aim to compare 3 different double layered suturing methods [ double layer locking versus double layer unlocking versus Babu and Magon technique (Far Far Near Near technique)] and check technique results in thick scar without isthmocele formation. Following 6-12 months of caesarean section, we perform a vaginal scan to check the whether the scar is healed well or there is formation of isthmocele. In this way of research, we are trying to find out the effective method of suturing technique to reduce chances of rupture uterus in next pregnancy. |