NCT07889700

Brief Summary

The active phase of labor is a critical period for the progress of labor and maternal comfort. Non-pharmacological interventions such as birth ball exercises are frequently used to support labor progress and maternal mobility. Birth ball exercises may facilitate fetal descent, improve maternal pelvic mobility, and potentially shorten labor duration. Intrapartum ultrasound has recently emerged as an objective method for assessing labor progress and fetal head position. Compared with digital vaginal examination, intrapartum ultrasound provides more reliable and reproducible measurements. The aim of this study is to evaluate the effect of birth ball exercises performed during the active phase of labor on labor progress using intrapartum ultrasound. The findings of this study may contribute to understanding the potential benefits of birth ball exercises in supporting physiological labor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 22, 2026

Completed
Last Updated

October 22, 2026

Status Verified

October 1, 2026

Enrollment Period

9 months

First QC Date

May 4, 2026

Last Update Submit

October 16, 2026

Conditions

Keywords

Birth BallIntrapartum UltrasoundActive Phase of LaborLabor Progress

Outcome Measures

Primary Outcomes (5)

  • Angle of Progression (AoP) during the active phase of labor

    Angle of progression (AoP) was measured by transperineal intrapartum ultrasound. AoP was defined as the angle between the long axis of the pubic symphysis and a line drawn from the inferior edge of the pubic symphysis tangentially to the most distal point of the fetal skull. Measurements were obtained at 6 cm and 10 cm cervical dilation. AoP was expressed in degrees, with higher values indicating greater fetal head descent.

    At 6 cm and 10 cm cervical dilation during the active phase of labor

  • Head-Perineum Distance (HPD) during the active phase of labor

    Head-perineum distance (HPD) was measured by transperineal intrapartum ultrasound. HPD was defined as the shortest distance between the perineal skin surface and the outer bony limit of the fetal skull. Measurements were obtained at 6 cm and 10 cm cervical dilation. Lower HPD values indicate greater fetal head descent. HPD was expressed in centimeters.

    At 6 cm and 10 cm cervical dilation during the active phase of labor

  • Progression Distance (PD) during the active phase of labor

    Progression distance (PD) was measured by transperineal intrapartum ultrasound. PD was defined as the distance between the infrapubic line and the most distal point of the fetal skull. Measurements were obtained at 6 cm and 10 cm cervical dilation, and changes in PD reflected fetal head progression through the birth canal. PD was expressed in centimeters.

    At 6 cm and 10 cm cervical dilation during the active phase of labor

  • Fetal Head Direction (HD) during the active phase of labor

    Fetal head direction (HD) was assessed by transperineal intrapartum ultrasound according to the orientation of the fetal head within the maternal pelvis. Head direction was categorized as downward, horizontal, or upward. Assessments were performed at 6 cm and 10 cm cervical dilation. The outcome measure was reported categorically as downward, horizontal, or upward.

    At 6 cm and 10 cm cervical dilation during the active phase of labor

  • Fetal Head Position during the active phase of labor

    Fetal head position was assessed by intrapartum ultrasound according to the orientation of the fetal occiput within the maternal pelvis. Fetal head position was categorized as occiput anterior, occiput transverse, or occiput posterior. Assessments were performed at 6 cm and 10 cm cervical dilation. The outcome measure was reported categorically as occiput anterior, occiput transverse, or occiput posterior.

    At 6 cm and 10 cm cervical dilation during the active phase of labor

Secondary Outcomes (2)

  • Duration of the active phase of labor

    During labor

  • Mode of delivery

    At delivery

Study Arms (2)

Birth Ball Exercise Group

EXPERIMENTAL

Pregnant women in the active phase of labor will perform birth ball exercises under supervision.

Behavioral: Birth Ball Exercise

Control Group

NO INTERVENTION

Participants will receive routine labor management without birth ball exercises.

Interventions

Birth ball exercises performed during the active phase of labor to facilitate labor progress.

Birth Ball Exercise Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women aged 18-35 years
  • Nulliparous women
  • Singleton pregnancy
  • Cephalic presentation
  • Gestational age between 38 and 40 weeks
  • Expected vaginal delivery
  • Cervical dilation ≥6 cm (active phase of labor)
  • Ability to perform birth ball exercises
  • Ability to provide informed consent

You may not qualify if:

  • Multiple pregnancy
  • Non-cephalic presentation
  • Previous uterine surgery
  • Obstetric risk factors
  • Obstetric complications during labor (e.g., vaginal bleeding, fetal distress)
  • Gestational age \<37 weeks at admission
  • Alcohol or substance abuse
  • Inability to perform birth ball exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

(Sakarya Üniversitesi Eğitim ve Araştırma Hastanesi) Department of Obstetrics and Gynecology

Sakarya, 54000, Turkey (Türkiye)

Location

Study Officials

  • Hilal Uslu Yuvacı, MD

    (Sakarya Üniversitesi Eğitim ve Araştırma Hastanesi) Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either a birth ball exercise group or a control group during the active phase of labor.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

October 22, 2026

Study Start

November 2, 2025

Primary Completion

July 16, 2026

Study Completion

September 1, 2026

Last Updated

October 22, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations