NCT07663500

Brief Summary

This prospective, three-arm, non-randomized quasi-experimental study aims to evaluate integrated intrapartum supportive care combined with different pushing strategies among women at 37-42 weeks of gestation who receive low-dose epidural analgesia. Participants receive integrated intrapartum supportive care combined with spontaneous pushing, integrated intrapartum supportive care combined with immediate pushing, or routine intrapartum care combined with immediate pushing. The primary outcomes are the durations of the first and second stages of labor. Secondary outcomes include mode of birth, obstetric interventions, maternal outcomes, and neonatal outcomes.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 10, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 17, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

Integrated intrapartum supportive careSpontaneous pushingImmediate pushingLow-dose epidural analgesiaMaternal mobilityLabor progression

Outcome Measures

Primary Outcomes (1)

  • Duration of the first and second stages of labor

    The duration of the first stage of labor is defined as the time interval from the onset of active labor-marked by regular, painful uterine contractions and cervical dilation of ≥6 cm-until full cervical dilation (10 cm). The duration of the second stage of labor is defined as the time from full cervical dilation to the complete delivery of the fetus. Labor durations will be recorded in minutes based on partograph entries and electronic medical records, with all timings verified by attending midwives or obstetric care providers to ensure accuracy.

    From the onset of active labor to the delivery of the fetus.

Secondary Outcomes (3)

  • Caesarean Section Rate

    During labor and delivery

  • Instrumental Vaginal Delivery Rate

    During delivery

  • Augmentation Rate

    During labor

Study Arms (3)

Integrated Care with Spontaneous Pushing

EXPERIMENTAL

Integrated Care with Spontaneous Pushing Group

Behavioral: Integrated Care with Spontaneous Pushing Group

Integrated Care with Immediate Pushing

EXPERIMENTAL

Integrated Care with Immediate Pushing Group

Behavioral: Integrated Care with Immediate Pushing

Standard Routine Care

ACTIVE COMPARATOR

Standard Routine Care

Behavioral: Standard Routine Care

Interventions

Integrated Care with Immediate Pushing Group: Participants receive an integrated intrapartum care package that includes continuous labor support and active birth positioning. Once full cervical dilation is achieved, participants are instructed to begin pushing immediately, regardless of the presence or absence of an urge to push. This directive approach to second-stage labor is guided by midwives or obstetric staff.

Integrated Care with Immediate Pushing

Participants receive the integrated intrapartum supportive care program during the first stage of labor. During the second stage, participants are encouraged to begin pushing in response to their spontaneous urge to push rather than routinely initiating pushing immediately after full cervical dilation. The pushing strategy is implemented by the attending clinical care team according to the predefined group protocol.

Integrated Care with Spontaneous Pushing

Participants receive routine intrapartum care according to institutional clinical practice. Supportive measures and position changes may be provided according to maternal needs and clinical judgment, but participants do not receive the structured multicomponent integrated intrapartum supportive care program. During the second stage of labor, pushing begins after full cervical dilation according to the attending clinical team's immediate pushing practice.

Standard Routine Care

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly biological females who are pregnancy at 37-42 week will be eligible to participate in this study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiwan Adventist Hospital

Taipei, 10556, Taiwan

RECRUITING

Study Officials

  • Wan-Lin Pan, PhD

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start

June 10, 2025

Primary Completion

July 31, 2026

Study Completion

July 31, 2026

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

This study does not plan to share individual participant data.

Locations