Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT05578794
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2022-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Straining Techniques on Women and Newborn
Sponsor:
Cumhuriyet University
Organization:
Study Overview
Official Title:
The Effect of Straining Techniques on Duration of Labor, Perineal Trauma Status, and Newborn Apgar Score
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose: To examine the effects of straining techniques on the duration of labor, perineal trauma status and newborn apgar score.
Method: This study is a randomized controlled trial. The straining techniques were explained to the pregnant women who gave written consent to participate in the study and were randomly assigned to groups in the latent phase (natural, spontaneous, Valsalva), and the techniques were applied in the second phase of labor.
Method: This study is a randomized controlled trial. The straining techniques were explained to the pregnant women who gave written consent to participate in the study and were randomly assigned to groups in the latent phase (natural, spontaneous, Valsalva), and the techniques were applied in the second phase of labor.
Detailed Description:
Purpose: The present study was planned to determine the effects of straining techniques on the duration of labor, perineal trauma status, and newborn Apgar score.
Method: The study, which had a randomized-controlled experimental design, was conducted in Sivas Numune Hospital Birth Unit. The sampling size was calculated using power analysis. In the literature, spontaneous straining is used by pregnant women in the range of 25-81%, and Valsalva -type straining has a rate of 32-75%. To represent the population of the study, sample volume was determined at =0.05 significance level, 1- =0.95 Confidence Interval, =0.20 error risk, and 1- =0.80 power, and the total number of individuals was determined as 354. The data of the study were collected with the "Pre-Evaluation Form", "Personal Information Form", "Labor Evaluation Form", and "Apgar Score" created by the researchers in line with the literature data. The straining techniques were explained to the pregnant women who gave written consent to participate in the study and were randomly assigned to groups in the latent phase (natural, spontaneous, Valsalva), and the techniques were applied in the second phase of labor. ANOVA, Kruskal Wallis H-test, Chi-square test, Exact test, Tamhane T2 test, and Dunn Test were used to evaluate the data obtained in the study. Statistical significance was evaluated at a 0.05 significance level and the SPSS version 23.0 was used.
Method: The study, which had a randomized-controlled experimental design, was conducted in Sivas Numune Hospital Birth Unit. The sampling size was calculated using power analysis. In the literature, spontaneous straining is used by pregnant women in the range of 25-81%, and Valsalva -type straining has a rate of 32-75%. To represent the population of the study, sample volume was determined at =0.05 significance level, 1- =0.95 Confidence Interval, =0.20 error risk, and 1- =0.80 power, and the total number of individuals was determined as 354. The data of the study were collected with the "Pre-Evaluation Form", "Personal Information Form", "Labor Evaluation Form", and "Apgar Score" created by the researchers in line with the literature data. The straining techniques were explained to the pregnant women who gave written consent to participate in the study and were randomly assigned to groups in the latent phase (natural, spontaneous, Valsalva), and the techniques were applied in the second phase of labor. ANOVA, Kruskal Wallis H-test, Chi-square test, Exact test, Tamhane T2 test, and Dunn Test were used to evaluate the data obtained in the study. Statistical significance was evaluated at a 0.05 significance level and the SPSS version 23.0 was used.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: