The Effect of Straining Techniques on Women and Newborn

NCT ID: NCT05578794

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-24
• Study Completion Date: 2021-11-30

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.

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.

Conditions

Prolonged Second Stage of Labor; Other Specified Trauma to Perineum and Vulva During Delivery; Newborn; Vitality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Valsalva Straining (Control Group)

The straining techniques for the groups were explained by the researcher in line with the process steps in the latent phase. Valsalva straining is supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.

Group Type: EXPERIMENTAL

Straining types

Intervention Type: OTHER

Valsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.

Spontaneous Straining

The straining techniques for the groups were explained by the researcher in line with the process steps in the latent phase. Spontaneous straining is supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.

Group Type: EXPERIMENTAL

Straining types

Intervention Type: OTHER

Valsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.

Natural Straining

The straining techniques for the groups were explained by the researcher in line with the process steps in the latent phase. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.

Group Type: EXPERIMENTAL

Straining types

Intervention Type: OTHER

Valsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.

Interventions

Straining types

Valsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 38-42. being at the gestational week,
• Having a singleton pregnancy
• Fetus in vertex position
• Being in the latent phase in the first stage of labor
• Planning and having a normal vaginal birth,
• Not having a diagnosed chronic physical disease,
• Not having a diagnosed psychiatric disease,
• No risk of risky pregnancy or fetal anomaly,
• Being literate,
• No communication problem
• Giving birth in the lithotomy position
• Volunteering to participate in the study

Exclusion Criteria

• 38-42. not in the week of pregnancy,
• Having multiple pregnancy
• Fetus out of vertex position
• Being in the latent phase in the first stage of birth,
• Having a cesarean section while planning a normal vaginal delivery,
• Having a diagnosed chronic physical illness,
• Having a diagnosed psychiatric illness,
• Having a risky pregnancy or fetal anomaly risk,
• illiteracy,
• Having a communication problem
• Giving birth in different positions
• Not willing to participate in the study

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Ozlem Akgün

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulbahtiyar Demirel

Role: PRINCIPAL_INVESTIGATOR

Cumhuriyet University

Locations

Sivas sample hospital

Sivas, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Related Links

http://doi.org/10.1097/GRF.0000000000000113

Second Stage of Labor

http://doi.org/10.1016/j.midw.2020.102843

Is directed open-glottis pushing more effective than directed closed-glottis pushing during the second stage of labor? A pragmatic randomized trial-the EOLE study.

http://www.sjmms.net/text.asp?2014/2/2/101/137000

The impact of valsalva's versus spontaneous pushing techniques during second stage of labor on postpartum maternal fatigue and neonatal outcome.

Other Identifiers

OAkgun

Identifier Type: -

Identifier Source: org_study_id