The Effect of Straining Techniques on Women and Newborn

NCT05578794 | Completed

• 1 other identifier: OAkgun
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• The distribution of the duration of the second phase according to the straining styles of women in labor

  The distribution of the duration of the second phase was evaluated according to the pushing styles of the women who gave birth. The duration of the second stage of labor was calculated by keeping the hours and minutes according to the type of straining used. The time from the woman's full dilation (10 cm) to the birth of the baby was measured.

  2-90 minute

• The perineal trauma status according to the straining styles of women during labor

  Perineal trauma status of women was evaluated according to their pushing styles during delivery. Episiotomy or laceration status after delivery of the placenta was evaluated by observation and examination method.

  10-30 minute

• The distribution of the mean Apgar Scores of the newborns according to the straining types of women during labor

  The newborn apgar scores were evaluated according to the straining types of the women at the time of delivery. Apgar Score is the expression of the physiological condition of the infant at a certain time (ACOG, 2015). In studies examining the relationship between mortality rates and Apgar scores, it was shown that infants with low scores (0-2) had higher mortality rates (14%). Infants with high scores (7-10) had lower mortality rates (0.13%). The scoring system showed that overall Apgar scores of infants born with cesarean section were lower than those born vaginally (Apgar, 1966; Rubarth, 2012). Apgar developed this evaluation tool with 5 objective criteria (heart rate, respiration, reflex irritability, muscle tonus, and color). The Apgar Evaluation System is used in the 1st and 5th minutes after the infant is born. Apgar scores of 7-10 are reassuring, normal, 4-6 moderately abnormal, and 0-3 are considered low in term and preterm infants (ACOG, 2015).

  1-5 minute

Secondary Outcomes (1)

• The distribution of women's satisfaction and considerations about the practice according to the way they strain during labor

  30 minute- 4 hours

Study Arms (3)

Valsalva Straining (Control Group)

EXPERIMENTAL

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.

Other: Straining types

Spontaneous Straining

EXPERIMENTAL

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.

Other: Straining types

Natural Straining

EXPERIMENTAL

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.

Other: Straining types

Interventions

Straining types 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; Spontaneous Straining; Valsalva Straining (Control Group)

Eligibility Criteria

• Age: 19 Years - 41 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas sample hospital

Sivas, Turkey (Türkiye)

Location

Related Links

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

Study Officials

• Gulbahtiyar Demirel

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Valsalva-type Straining (Group I), Spontaneous Straining (Group II), Natural Straining (Group III))

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 13, 2022
• Study Start: February 24, 2020
• Primary Completion: March 15, 2021
• Study Completion: November 30, 2021
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)