NCT07745192

Brief Summary

This randomized clinical study evaluated the effects of a lateral position with hip flexion and femoral internal rotation during the second stage of labor in nulliparous women receiving epidural labor analgesia. Participants were assigned to either an observation group using the modified lateral position or a control group using the conventional lateral position. The study compared second-stage labor duration, additional obstetric interventions, maternal outcomes, perineal outcomes, and neonatal outcomes between the two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

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

February 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

second stage of laborepidural labor analgesiamaternal positionlateral positionhip flexionfemoral internal rotation

Outcome Measures

Primary Outcomes (2)

  • Duration of the Second Stage of Labor

    From full cervical dilatation to delivery of the neonate

  • Additional Obstetric Interventions During the Second Stage of Labor

    Additional obstetric interventions during the second stage of labor, classified as none, forceps-assisted vaginal birth, cesarean delivery during the second stage, vaginal birth after manual fetal-head rotation, or vaginal birth with episiotomy as the principal intervention.

    During the second stage of labor

Secondary Outcomes (4)

  • Duration of the First Stage of Labor

    From onset of regular uterine contractions to full cervical dilatation

  • Duration of the Third Stage of Labor

    From delivery of the neonate to delivery of the placenta

  • Postpartum Blood Loss

    Within 2 hours after delivery

  • Perineal Outcomes

    At delivery

Study Arms (2)

Modified Lateral Position Group

EXPERIMENTAL

Participants in this group adopted a lateral position with hip flexion and femoral internal rotation during the second stage of labor under midwife assistance.

Behavioral: Lateral Position With Hip Flexion and Femoral Internal Rotation

Conventional Lateral Position Group

ACTIVE COMPARATOR

Participants in this group adopted the conventional lateral position during the second stage of labor under routine intrapartum care and midwife

Behavioral: Conventional Lateral Position

Interventions

Participants adopted a modified lateral position during the second stage of labor. The position involved lateral positioning facing the side opposite to the fetal back, hip flexion, knee flexion, and 30°-40° femoral internal rotation with midwife assistance. The position was used during uterine contractions with guided bearing-down efforts and was alternated with a semi-recumbent position according to the study protocol.

Modified Lateral Position Group

Participants adopted the conventional lateral position during the second stage of labor under routine intrapartum care and midwife assistance. During uterine contractions, participants performed bearing-down efforts in the lateral position, followed by intervals of rest and semi-recumbent positioning according to the study protocol.

Conventional Lateral Position Group

Eligibility Criteria

Age22 Years - 34 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nulliparous women.
  • Age 22 to 34 years.
  • Singleton pregnancy.
  • Cephalic presentation confirmed by ultrasonography after 37 weeks of gestation.
  • Gestational age of 37 to 41 weeks.
  • Estimated fetal weight of 2,500 to 3,500 g.
  • No birth-canal abnormalities on vaginal examination.
  • Effective epidural labor analgesia during the first stage of labor.
  • Sufficient cognitive capacity to understand and cooperate with the study procedures.
  • Ability and willingness to provide written informed consent.

You may not qualify if:

  • Organic heart, liver, or kidney disease.
  • Prenatal indication for cesarean delivery.
  • Pubic symphysis separation.
  • Lower-limb disease or impaired mobility.
  • Precipitous labor.
  • Second stage of labor lasting less than 30 minutes.
  • Severe mental illness.
  • Fetal malformation.
  • Withdrawal from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanpu Branch of The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

February 1, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

August 4, 2026

Record last verified: 2026-07

Locations