Clinical trial NCT05578794: The Effect of Straining Techniques on Women and Newborn
Official title: The Effect of Straining Techniques on Duration of Labor, Perineal Trauma Status, and Newborn Apgar Score
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Second Stage of Labor
Other Specified Trauma to Perineum and Vulva During Delivery
Newborn; Vitality
Keywords: Labor
Midwife
Pregnant
Straining techniques
Perineal trauma
Apgar Score
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 354
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Valsalva-type Straining (Group I), Spontaneous Straining (Group II), Natural Straining (Group III))
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The distribution of the duration of the second phase according to the straining styles of women in labor
timeFrame: 2-90 minute
measure: The perineal trauma status according to the straining styles of women during labor
timeFrame: 10-30 minute
measure: The distribution of the mean Apgar Scores of the newborns according to the straining types of women during labor
timeFrame: 1-5 minute
Secondary outcomes:
measure: The distribution of women's satisfaction and considerations about the practice according to the way they strain during labor
timeFrame: 30 minute- 4 hours
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas sample hospital
Study officials:
affiliation: Cumhuriyet University
name: Gulbahtiyar Demirel
role: PRINCIPAL_INVESTIGATOR
References: