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Primipara PregnantNCT07243522

The Effect of Birth Positions on Labor

A study testing Semi-sitting birth position in people with Primipara Pregnant and Primipara Labour, run by Ege University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Primipara Pregnant, Primipara Labour
What is being tested?
Semi-sitting birth position
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Oct 2025to 7 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emine Demir, Research Assistant contact

+90 232 311 83 00

demiremine0146@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Izmir Bakircay University Cigli Training and Research Hospital

    Izmir

    Ayse Rabia Kanbak, Associate Professor, +90 232 398 37 00, draysekanbak@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Read the detailed description

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.

Being tested
Semi-sitting birth position
Keywords
birth positions, pelvic floor, perineal pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semi-sitting birth positionOther

    Pregnant women who present to the maternity unit, meet the inclusion criteria, are assigned to the intervention group after randomization, and agree to participate in the study will be informed about birthing positions by the primary investigator. During the pilot study for the study, it was determined that the ideal position, considering clinical conditions, patient safety, and comfort, is Semi-sittin. Therefore, pregnant women in the intervention group will deliver in the Semi-sitting position.

Study groups in NCT07243522
Study groupRoleWhat they receive
Control Group (Lithotomy Position Group)No interventionNot described
Intervention Group (Semi-sitting Position Group)ExperimentalNot described
Receives: Other: Semi-sitting birth position

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pelvic Floor Muscle Strength Measurement

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

    Measured: From enrollment to the end of postpartum at 6 months

Secondary outcomes (1)
  1. Perineal Pain

    The severity and nature of perineal pain will be measured with the McGill Pain Scale Short Form.

    Measured: From enrollment to the end of postpartum at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start7 Oct 2025
  3. Primary completion1 Mar 2026
  4. Study completion7 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07243522
Sponsor's protocol ID
25-AKD-139
Status last verified
Dec 2025
First submitted
14 Nov 2025
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bozkurt M, Yumru AE, Sahin L. Pelvic floor dysfunction, and effects of pregnancy and mode of delivery on pelvic floor. Taiwan J Obstet Gynecol. 2014 Dec;53(4):452-8. doi: 10.1016/j.tjog.2014.08.001.

    PubMed 25510682
  • Catanzarite T, Bremner S, Barlow CL, Bou-Malham L, O'Connor S, Alperin M. Pelvic muscles' mechanical response to strains in the absence and presence of pregnancy-induced adaptations in a rat model. Am J Obstet Gynecol. 2018 May;218(5):512.e1-512.e9. doi: 10.1016/j.ajog.2018.02.001. Epub 2018 Feb 9.

    PubMed 29432755
  • Alperin M, Lawley DM, Esparza MC, Lieber RL. Pregnancy-induced adaptations in the intrinsic structure of rat pelvic floor muscles. Am J Obstet Gynecol. 2015 Aug;213(2):191.e1-7. doi: 10.1016/j.ajog.2015.05.012. Epub 2015 May 13.

    PubMed 25979618
  • Hofmeyr GJ, Vogel JP, Singata M, Habib NA, Landoulsi S, Gulmezoglu AM. Does gentle assisted pushing or giving birth in the upright position reduce the duration of the second stage of labour? A three-arm, open-label, randomised controlled trial in South Africa. BMJ Glob Health. 2018 Jun 29;3(3):e000906. doi: 10.1136/bmjgh-2018-000906. eCollection 2018.

    PubMed 29989055
  • Dabral, A., Pawar, P., Bharti, R., Kumari, A., Batra, A., ve Arora, R. (2018). Upright kneeling position during second stage of labor: a pilot study. Int J Reprod Contracept Obst Gynecol, 7(2), (s.401-407).

  • Berta M, Lindgren H, Christensson K, Mekonnen S, Adefris M. Effect of maternal birth positions on duration of second stage of labor: systematic review and meta-analysis. BMC Pregnancy Childbirth. 2019 Dec 4;19(1):466. doi: 10.1186/s12884-019-2620-0.

    PubMed 31801479
  • Deliktas A, Kukulu K. A meta-analysis of the effect on maternal health of upright positions during the second stage of labour, without routine epidural analgesia. J Adv Nurs. 2018 Feb;74(2):263-278. doi: 10.1111/jan.13447. Epub 2017 Oct 4.

    PubMed 28881046
  • Gupta JK, Sood A, Hofmeyr GJ, Vogel JP. Position in the second stage of labour for women without epidural anaesthesia. Cochrane Database Syst Rev. 2017 May 25;5(5):CD002006. doi: 10.1002/14651858.CD002006.pub4.

    PubMed 28539008
  • Walker KF, Kibuka M, Thornton JG, Jones NW. Maternal position in the second stage of labour for women with epidural anaesthesia. Cochrane Database Syst Rev. 2018 Nov 9;11(11):CD008070. doi: 10.1002/14651858.CD008070.pub4.

    PubMed 30411804
  • Zang Y, Lu H, Zhang H, Zhang X, Yang M, Huang J. Chinese midwives' perceptions on upright positions during the second stage of labour: A qualitative study. Midwifery. 2021 Jul;98:102993. doi: 10.1016/j.midw.2021.102993. Epub 2021 Mar 19.

    PubMed 33823359
  • Zang Y, Lu H, Zhang H, Huang J, Zhao Y, Ren L. Benefits and risks of upright positions during the second stage of labour: An overview of systematic reviews. Int J Nurs Stud. 2021 Feb;114:103812. doi: 10.1016/j.ijnurstu.2020.103812. Epub 2020 Oct 29.

    PubMed 33217662

Questions about this trial

What is this clinical trial studying?

A study testing Semi-sitting birth position in people with Primipara Pregnant and Primipara Labour, run by Ege University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emine Demir, Research Assistant (+90 232 311 83 00, demiremine0146@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pelvic Floor Muscle Strength Measurement (time frame: From enrollment to the end of postpartum at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07243522, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

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