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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNational Taipei University of Nursing and Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

159 Participants
are divided into 3 treatment groups
Group A: Integrated Care with Spontaneous PushingExperimental treatment 1 intervention
Group B: Integrated Care with Immediate PushingExperimental treatment 1 intervention
Group C: Standard Routine CareActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Caesarean Section Rate

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.

Time frame
During labor and delivery
2

Instrumental Vaginal Delivery Rate

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.

Time frame
During delivery
3

Augmentation Rate

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.

Time frame
During labor

Other outcomes

Sponsors and contacts

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