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临床试验/NCT07243522
NCT07243522招募中不适用

The Effect of Birth Positions on Pelvic Floor Muscle Strength, Severity, and Quality of Perineal Pain in Primiparous Pregnant Women: A Randomized Controlled Trial

Ege University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Pelvic Floor Muscle Strength Measurement

研究概览

简要总结

This study is a randomized controlled trial aimed at evaluating the effects of positions used during labor on pelvic floor muscle strength and the severity and nature of perineal pain in primiparous pregnant women. The World Health Organization (WHO) recommends supporting women's freedom of movement during the second stage of labor and encouraging upright birthing positions. However, in many countries, births are still performed in supine or lithotomy positions, and knowledge and practice regarding upright positions persist. This situation points to a significant knowledge and practice gap for both birthing women and healthcare professionals.

The study will be conducted at the Birth Unit of Bakırçay University Çiğli Training and Research Hospital, Izmir. Following ethics committee approval, the study will be conducted within one year. The sample will consist of 70 primiparous pregnant women who present to the birth unit and meet the inclusion criteria. Participants will be randomly assigned to the intervention and control groups via random.org. Pregnant women in the intervention group will deliver in the Semi-Fowler's (semi-sitting) position, while those in the control group will deliver in the lithotomy position, which is the hospital's standard practice.

Data will be collected in two stages. In the first stage, data will be collected at the onset of labor and when cervical dilation reaches 8-10 cm. In the second stage, data will be collected within 24 hours after delivery, at 6 weeks and 6 months postpartum. Data collection tools will be administered to each woman a total of five times in the first and second stages. Pelvic floor muscle strength will be assessed both objectively with a perineometer and subjectively with the Oxford scale. The severity and nature of perineal pain will be measured with the McGill Pain Scale Short Form.

The hypotheses of the study are that delivering in a semi-sitting position will increase pelvic floor muscle strength and reduce perineal pain. The data will be analyzed using the SPSS 23 software package, using parametric and non-parametric tests. Intention-to-treat (ITT) analysis will be applied when necessary to mitigate the impact of data loss.

This study aims to evaluate not only the effects of birthing positions on the labor process but also their impact on women's health in the postpartum period. This research, which will contribute to expanding the limited literature on this topic, is also expected to support the widespread adoption of a woman-centered approach to care in maternity services.

详细描述

This study is a randomized controlled trial aimed at evaluating the effects of positions used during labor on pelvic floor muscle strength and the severity and nature of perineal pain in primiparous pregnant women. The World Health Organization (WHO) recommends supporting women's freedom of movement during the second stage of labor and encouraging upright birthing positions. However, in many countries, births are still performed in supine or lithotomy positions, and knowledge and practice regarding upright positions persist. This situation points to a significant knowledge and practice gap for both birthing women and healthcare professionals.

The study will be conducted at the Birth Unit of Bakırçay University Çiğli Training and Research Hospital, Izmir. Following ethics committee approval, the study will be conducted within one year. The sample will consist of 70 primiparous pregnant women who present to the birth unit and meet the inclusion criteria. Participants will be randomly assigned to the intervention and control groups via random.org. Pregnant women in the intervention group will deliver in the Semi-Fowler's (semi-sitting) position, while those in the control group will deliver in the lithotomy position, which is the hospital's standard practice.

Data will be collected in two stages. In the first stage, data will be collected at the onset of labor and when cervical dilation reaches 8-10 cm. In the second stage, data will be collected within 24 hours after delivery, at 6 weeks and 6 months postpartum. Data collection tools will be administered to each woman a total of five times in the first and second stages. Pelvic floor muscle strength will be assessed both objectively with a perineometer and subjectively with the Oxford scale. The severity and nature of perineal pain will be measured with the McGill Pain Scale Short Form.

The hypotheses of the study are that delivering in a semi-sitting position will increase pelvic floor muscle strength and reduce perineal pain. The data will be analyzed using the SPSS 23 software package, using parametric and non-parametric tests. Intention-to-treat (ITT) analysis will be applied when necessary to mitigate the impact of data loss.

This study aims to evaluate not only the effects of birthing positions on the labor process but also their impact on women's health in the postpartum period. This research, which will contribute to expanding the limited literature on this topic, is also expected to support the widespread adoption of a woman-centered approach to care in maternity services.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Being between 18 and 35 years of age
  • •Being primiparous
  • •Being at term (37-42 weeks)
  • •Being in the latent phase of the first stage of labor
  • •Being in the vertex position, having a single, live fetus
  • •Having an estimated fetal weight between 2500 and 4000 grams
  • •Having a maternal Body Mass Index <30
  • •Pregnant women who are expected to give birth vaginally
  • •Ability to understand and speak Turkish
  • •Volunteer to participate in the study

排除标准

  • •Non-cephalic presentation
  • •Chronic diseases (heart disease, epilepsy, hypertension, hypothyroidism, diabetes, and kidney disease, etc.)
  • •Risk of obstetric complications (gestational hypertension, cephalopelvic disproportion, antepartum hemorrhage, intrauterine growth restriction, premature rupture of membranes, etc.)
  • •History of pelvic surgery
  • •History of prolapse surgery
  • •History of collagen disorder
  • •Severe anemia
  • •Presence of genital tract infection
  • •Abnormalities of the vulva (presence of vulvar edema, scarring, etc.)
  • •Application of fundal pressure
  • •Interventional delivery (use of forceps/vacuum during the second stage, etc.)
  • •Cesarean section
  • •Fetal (risk/presence of congenital malformations, estimated fetal weight <2500 g or >4000 g)

研究组 & 干预措施

Control Group (Lithotomy Position Group)

No Intervention

Intervention Group (Semi-sitting Position Group)

Experimental

干预措施: Semi-sitting birth position (Other)

结局指标

主要结局

Pelvic Floor Muscle Strength Measurement

时间窗: From enrollment to the end of postpartum at 6 months

Pelvic floor muscle strength will be assessed both objectively with a perineometer and subjectively with the Oxford scale.

次要结局

  • Perineal Pain(From enrollment to the end of postpartum at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emine Demir

Research Assistant (Principal Investigator)

Ege University

研究点 (1)

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