COMPARISON OF INTRA OPERATIVE HEMORRHAGE BY BLUNT AND SHARP EXPANSION OF UTERINE INCISION AT CESAREAN SECTION

Last registered on December 22, 2020

Pre-Trial

Trial Information

General Information

Title
COMPARISON OF INTRA OPERATIVE HEMORRHAGE BY BLUNT AND SHARP EXPANSION OF UTERINE INCISION AT CESAREAN SECTION
RCT ID
AEARCTR-0006917
Initial registration date
December 18, 2020

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
December 22, 2020, 6:55 AM EST

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

Last updated
December 22, 2020, 6:58 AM EST

Last updated is the most recent time when changes to the trial's registration were published.

Locations

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
Background and Objective: the rate of cesarean section has increased over the 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 the cesarean section on mean maternal blood loss.
Methodology: This randomized controlled trial was conducted in the 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-operativehematocrit fall and Hemoglobin fall were noted in two groups and analyzed with help of SPSS version 10.
Results: There was a 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 the two groups was statistically significant-value=0.015(<0.05). More fall was seen in group B as compared to group A. Perioperativehemoglobin 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 the sharp uterine incision.
Keywords: Caesarean section, blunt uterine incision, sharputerine incision.
External Link(s)

Registration Citation

Citation
Faiza, Faiza. 2020. "COMPARISON OF INTRA OPERATIVE HEMORRHAGE BY BLUNT AND SHARP EXPANSION OF UTERINE INCISION AT CESAREAN SECTION." AEA RCT Registry. December 22. https://doi.org/10.1257/rct.6917
Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2014-01-14
Intervention End Date
2014-07-14

Primary Outcomes

Primary Outcomes (end points)
Perioperative hemoglobin and perioperative hematocrit fall
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Randomized control trial
Nonprobability consecutive sampling
Experimental Design Details
Randomization Method
lottery method
Randomization Unit
individuals
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
1
Sample size: planned number of observations
80 patients
Sample size (or number of clusters) by treatment arms
80 sample size 40 in each treatment arm
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

There are documents in this trial unavailable to the public. Use the button below to request access to this information.

Request Information

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