Effectiveness of Upright vs. Lithotomy Birthing Position on Maternal and Newborn Outcomes

NCT06670235 | Not Yet Recruiting DMC

• 1 other identifier: Birth Position
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effectiveness of upright versus lithotomy birthing positions on maternal and newborn outcomes. Conducted at the Maternity Teaching Hospital in Erbil City, it employs a quasi-experimental design with 62 women in each group (Intervention and control), comparing outcomes for those encouraged to use upright positions with those in standard lithotomy. Maternal and newborn outcomes will be assessed to provide evidence on how birthing positions impact labor progression, comfort, and delivery results. The findings aim to inform clinical practice and policy, enhancing midwifery care and supporting patient-centered approaches to childbirth. Does the upright birthing position effect on maternal and newborn outcomes? Does the lithotomy birthing position effect on maternal and newborn outcomes? The expected outcomes will decrease the rate of perineal tear , episiotomy , post partum hemorrhage and decreasing the rate of admission to Neonatal Intensive Care Unit (NICU) in newborn.

Conditions

Maternal Outcomes; Newborn Complication

Keywords

Upright birthing position; Lithotomy position; Maternal outcomes in childbirth; Newborn outcomes in labor; Birth position comparison; Labor positions and delivery; Effectiveness of birth positions

Outcome Measures

Primary Outcomes (2)

• Maternal Labor Duration

  The total time from the onset of active labor until delivery. Measurement Method: Measured in minutes and seconds recording by using the stopwatch from mobile clock.

  Assessed continuously from the onset of active labor until delivery.

• Newborn Apgar score

  Apgar score at 1 , 5 and 10 minutes post-delivery, Measurement Method: from 0 to 2, with a maximum total score of 10, (Color, Heart rate, Reflex, Muscle Tone, Breath). Total Score Interpretation 7-10: Generally normal; baby is likely to be in good health. 4-6: Intermediate; may need some help with breathing or other care. 0-3: Critical; immediate resuscitative efforts are typically required.

  Immediately after delivery , Assessed at 1 minute , 5 minutes and 10 minutes post-delivery

Secondary Outcomes (3)

• Maternal Perception of Pain and Comfort

  Assessed during labor (intervals to be specified, e.g., every 2 hours) and immediately after delivery.

• Postpartum Hemorrhage (PPH)

  Estimated immediately following delivery and up to 2 hours postpartum.

• Maternal Satisfaction with the Birth Experience

  Assessed within the first 2 hours postpartum, typically before hospital discharge.

Study Arms (2)

Upright Birthing Position Group

EXPERIMENTAL

Participants assigned to the Upright Birthing Position Arm will be encouraged to maintain an upright position during labor and delivery. The upright position includes a squatting. This arm aims to assess the potential benefits of the upright position, such as improved maternal outcomes (e.g., shorter labor duration, reduced need for interventions) and favorable newborn outcomes (e.g., higher Apgar scores, better oxygenation). To evaluate the effects of upright positioning on both maternal and newborn outcomes compared to the traditional lithotomy position.

Behavioral: Upright Birthing Position

Lithotomy Birthing Position

ACTIVE COMPARATOR

Participants in the Lithotomy Position Arm will follow the standard hospital practice of delivering in the lithotomy position, where the mother is lying on her back with legs supported in stirrups. This position is widely used in clinical settings and serves as the control arm to compare with the outcomes from the upright birthing position. To serve as a control group to provide a comparative measure of maternal and newborn outcomes against the upright birthing position. Outcomes will include maternal comfort, labor duration, intervention requirements, and newborn health indicators.

Behavioral: Lithotomy Birthing Position

Interventions

Upright Birthing Position BEHAVIORAL

This intervention involves encouraging participants to use an upright position during labor and delivery, which may include : squatting, based on their preference and comfort level. Healthcare staff will support the participants in maintaining an upright position throughout labor as much as possible to evaluate its effects on maternal and newborn outcomes.

Upright Birthing Position Group

Lithotomy Birthing Position BEHAVIORAL

Participants in this arm will be positioned in the lithotomy position during labor and delivery, which is a common practice in clinical settings. In this position, the mother lies on her back with her legs supported in stirrups. This intervention serves as the control condition to provide a baseline comparison for evaluating outcomes against the upright birthing position.

Lithotomy Birthing Position

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women with singleton pregnancies;
• Gestational age ranges from (≥37 to 41+6 weeks);
• Spontaneous labor with no contraindications to upright positions;
• Active phase of first stage labor;
• Age 18-35 years old;
• Normal size fetus with occipito-anterior position;
• Communicate normally and participate voluntary.

You may not qualify if:

• Abnormal fetal position (malpresentation) (e,g., persistent occipital-transverse and occipital-posterior position, etc.);
• Risky pregnancy or childbirth complications, such as (preeclampsia, eclampsia, heart disease, cephalic presentation dystocia, antepartum hemorrhage, fetal distress, intra-uterine growth restriction, intra-amniotic infection); and free from any chronic diseases (heart disease, epilepsy, hypertension, diabetes mellitus and renal disease)
• Multiple gestation;
• Cephalopelvic disproportion (CPD);
• Precipitate labor;
• Antenatally diagnosed fetal anomalies;
• Current history of a leg injury, fracture, and deep vein thrombosis.

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler Medical University, Erbil, Kurdistan region 44001

Erbil, 44001, Iraq

Location

Related Publications (5)

• Zhang H, Huang S, Guo X, Zhao N, Lu Y, Chen M, Li Y, Wu J, Huang L, Ma F, Yang Y, Zhang X, Zhou X, Guo R, Cai W. A randomised controlled trial in comparing maternal and neonatal outcomes between hands-and-knees delivery position and supine position in China. Midwifery. 2017 Jul;50:117-124. doi: 10.1016/j.midw.2017.03.022. Epub 2017 Mar 31.

  PMID: 28414983 BACKGROUND

• Cook JA, Julious SA, Sones W, Hampson LV, Hewitt C, Berlin JA, Ashby D, Emsley R, Fergusson DA, Walters SJ, Wilson ECF, Maclennan G, Stallard N, Rothwell JC, Bland M, Brown L, Ramsay CR, Cook A, Armstrong D, Altman D, Vale LD. DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials. 2018 Nov 5;19(1):606. doi: 10.1186/s13063-018-2884-0.

  PMID: 30400926 BACKGROUND

• Fu L, Huang J, Li D, Wang H, Xing L, Wei T, Hou R, Lu H. Effects of Using Sitting Position versus Lithotomy Position during the Second Stage of Labour on Maternal and Neonatal Outcomes and the Childbirth Experience of Chinese Women: A Prospective Cohort Study. Healthcare (Basel). 2023 Nov 20;11(22):2996. doi: 10.3390/healthcare11222996.

  PMID: 37998488 BACKGROUND

• Elvander C, Ahlberg M, Thies-Lagergren L, Cnattingius S, Stephansson O. Birth position and obstetric anal sphincter injury: a population-based study of 113 000 spontaneous births. BMC Pregnancy Childbirth. 2015 Oct 9;15:252. doi: 10.1186/s12884-015-0689-7.

  PMID: 26453177 BACKGROUND

• Abdolahian S, Ghavi F, Abdollahifard S, Sheikhan F. Effect of dance labor on the management of active phase labor pain & clients' satisfaction: a randomized controlled trial study. Glob J Health Sci. 2014 Mar 30;6(3):219-26. doi: 10.5539/gjhs.v6n3p219.

  PMID: 24762366 BACKGROUND

Central Study Contacts

Wahida Ibrahim, Master

CONTACT

009647509663311; Wahida.ibraheem@hmu.edu.krd

Dr. Kazhan Mahmood, PhD

CONTACT

009647504491331; kazhan.mahmood@hmu.edu.krd

Study Design

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

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 1, 2024
• Study Start: November 10, 2024
• Primary Completion: October 25, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)