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Recruiting NCT07663500

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

No phase Interventional Labor, Obstetric Epidural Analgesia, Obstetric Labor Duration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Integrated Care with Immediate Pushing, Integrated Care with Spontaneous Pushing Group, Standard Routine Care.
Who it may be relevant to
Registry conditions: Labor, Obstetric, Epidural Analgesia, Obstetric, Labor Duration. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Integrated Care with Immediate Pushing
    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.
  • Behavioral Integrated Care with Spontaneous Pushing Group
    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.
  • Behavioral Standard Routine Care
    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 outcome measures

  • Duration of the first and second stages of labor [Time frame: From the onset of active labor to the delivery of the fetus.]
Secondary outcome measures (3)
  • Caesarean Section Rate [Time frame: During labor and delivery]
  • Instrumental Vaginal Delivery Rate [Time frame: During delivery]
  • Augmentation Rate [Time frame: During labor]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • Taiwan Adventist Hospital — Taipei

Identifiers

NCT: NCT07663500 · 2024E02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗