COMAPRISON OF INTRA OPERATIVEHEMORRHAGE BY BLUNT AND SHARP EXPANSION OF UTERINE INCISION AT CESAREAN SECTION

Last registered on January 09, 2021

Pre-Trial

Trial Information

General Information

Title
COMAPRISON OF INTRA OPERATIVEHEMORRHAGE BY BLUNT AND SHARP EXPANSION OF UTERINE INCISION AT CESAREAN SECTION
RCT ID
AEARCTR-0006916
Initial registration date
January 06, 2021

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
January 09, 2021, 5:54 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
Sgth

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2014-01-14
End date
2014-07-14
Secondary IDs
Abstract
OMAPRISON OF INTRA OPERATIVE HEMORRHAGE BY BLUNT AND SHARP EXPANSION OF UTERINE INCISION AT CESAREAN SECTION

ABSTRACT:

Background and Objective: the rate of cesarean section has increased over past many years. different techniques are used to reduce blood loss at cesarean section. The purpose of this study is to compare the effect of blunt and sharp uterine incision at cesarean section on mean maternal blood loss.

Methodology: This randomized controlled trial was conducted in department of Gynecology/obstetrics, POF Hospital, Wah Cantt from 14th Jan to 13th July 2014. Eighty women scheduled for lower segment cesarean section were randomized to either blunt uterine incision (n=40) or sharp uterine incision (n=40). Outcomes were noted in terms of Peri-operative hematocrit fall and Hemoglobin fall were noted in two groups and analyzed with help of SPSS version 10.

Results: There was significant decrease in mean perioperative hematocrit and hemoglobin in sharp uterine incision as compared to blunt uterine incision and the difference between the two is found to be statistically significant. Perioperative hematocrit fall in group A was (mean 3.21±SD 1.3) and perioperative hematocrit fall was (mean 4.2 ± SD2.17) in group B. The difference between two groups was statistically significant p-value=0.015(<0.05). More fall was seen in group B as compared to group A. Perioperative hemoglobin fall (mean ±SD) was (1.47±1.08) in group A versus (mean1.95 ± SD0.85) in group B. The difference was statistically significant among two groups with p value =0.031(<0.05)

Conclusion: Blunt expansion of uterine incision during lower segment cesarean section is better as it is associated with less hemoglobin and hematocrit fall than sharp uterine incision.

Key words: Caesarean section, blunt uterine incision, sharp uterine incision.



External Link(s)

Registration Citation

Citation
Faiza, Faiza. 2021. "COMAPRISON OF INTRA OPERATIVEHEMORRHAGE BY BLUNT AND SHARP EXPANSION OF UTERINE INCISION AT CESAREAN SECTION." AEA RCT Registry. January 09. https://doi.org/10.1257/rct.6916
Experimental Details

Interventions

Intervention(s)
Study was conducted at department of Gynecology, Pakistan Ordinance Factory Hospital, Wah Cantt from 14th Jan to 13th July 2012. 80 women scheduled for lower segment cesarean section through Pfannensteil incision were randomized to either blunt uterine incision (n=40) or sharp uterine incision (n=40). Peri-operative complications like hematocrit fall and Hemoglobin fall were noted in two groups and analyzed with help of SPSS version 10.
Intervention Start Date
2014-01-14
Intervention End Date
2014-07-14

Primary Outcomes

Primary Outcomes (end points)
peri operative blood loss
Primary Outcomes (explanation)
perioperative blood loss

Secondary Outcomes

Secondary Outcomes (end points)
injury to fetus ,extension of uterine incision
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
RCT
Experimental Design Details
RCT
Randomization Method
LOTTERY
Randomization Unit
INDIVIDUAL
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
40 IN ACH GROUP
Sample size: planned number of observations
80 PATIENTS
Sample size (or number of clusters) by treatment arms
40 PATIENTS IN EACH GROUP
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials