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NCT Number: NCT07663500

Integrated Intrapartum Supportive Care and Pushing Strategies in Women Receiving Low-Dose Epidural Analgesia

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.

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Key information

Conditions

Labor, Obstetric Epidural Analgesia, Obstetric Labor Duration

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taiwan Adventist Hospital

Taipei, 10556, Taiwan

Location status: Recruiting

Location contact

Wan-Lin Pan

CONTACT

[email protected]

0933710737

About this study

Participants are enrolled into one of three predefined care groups: (1) integrated intrapartum supportive care combined with spontaneous pushing (IC-SP), (2) integrated intrapartum supportive care combined with immediate pushing (IC-IP), or (3) routine intrapartum care combined with immediate pushing (RC-IP). Group allocation is determined prospectively according to the attending physician's established clinical practice. The RC-IP group receives the hospital's usual intrapartum care. Allocation is determined before implementation of the intervention and is not based on labor outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

low-risk pregnant women aged 18 years or older with a singleton, term pregnancy (37-42 weeks), spontaneous labor onset, and planning to receive low-dose epidural analgesia.

Exclusion criteria

Exclusion Criteria: multiple gestation, non-cephalic presentation, known major fetal anomalies, planned cesarean birth, contraindications to vaginal birth, contraindications to maternal mobility or epidural analgesia, or inability to provide informed consent.

Treatment and study plan

Integrated Care with Immediate Pushing

Behavioral

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 Spontaneous Pushing Group

Behavioral

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.

Standard Routine Care

Behavioral

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.

Primary outcomes

  1. Duration of the first and second stages of labor

    Time frame: From the onset of active labor to the delivery of the fetus.

    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.

Secondary outcomes

  1. Caesarean Section Rate

    Time frame: During labor and delivery

    The proportion of enrolled participants who undergo unplanned cesarean birth during labor or delivery. Indications for cesarean birth will be extracted from the medical record.

  2. Instrumental Vaginal Delivery Rate

    Time frame: During delivery

    The proportion of participants who undergo instrumental vaginal delivery using forceps or vacuum extraction. The use of instruments will be recorded based on delivery records, and indications will be documented when available.

  3. Augmentation Rate

    Time frame: During labor

    The proportion of participants who receive augmentation of labor after spontaneous onset. Administration details (timing, dosage, indication) will be obtained from medical records and partographs.

Study contacts

Contact information is provided by the study sponsor or research team.

Wan-Lin Pan, PhD

CONTACT

[email protected]

+886-2-2822-7101 ext. 7101

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study title

Integrated Intrapartum Supportive Care Combined With Different Pushing Strategies Among Women Receiving Low-Dose Epidural Analgesia: A Three-Arm Non-Randomized Quasi-Experimental Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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