Labor, ObstetricNCT07663500
Integrated Intrapartum Supportive Care and Pushing Strategies in Women Receiving Low-Dose Epidural Analgesia
A study testing Integrated Care with Immediate Pushing, Integrated Care with Spontaneous Pushing Group and Standard Routine Care in people with Labor, Obstetric and Epidural Analgesia, Obstetric, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor, Obstetric, Epidural Analgesia, Obstetric, Labor Duration
- What is being tested?
- Integrated Care with Immediate Pushing, Integrated Care with Spontaneous Pushing Group and Standard Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jun 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taiwan Adventist Hospital
Taipei, 10556
Wan-Lin Pan, 0933710737, wanlimp@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- Integrated Care with Immediate Pushing, Integrated Care with Spontaneous Pushing Group, Standard Routine Care
- Keywords
- Integrated intrapartum supportive care, Spontaneous pushing, Immediate pushing, Low-dose epidural analgesia, Maternal mobility, Labor progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Care with Immediate PushingBehavioural
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 GroupBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Care with Spontaneous Pushing | Experimental | Integrated Care with Spontaneous Pushing Group Receives: Behavioral: Integrated Care with Spontaneous Pushing Group |
| Integrated Care with Immediate Pushing | Experimental | Integrated Care with Immediate Pushing Group Receives: Behavioral: Integrated Care with Immediate Pushing |
| Standard Routine Care | Active comparator | Standard Routine Care Receives: Behavioral: Standard Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the onset of active labor to the delivery of the fetus.
Secondary outcomes (3)
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.
Measured: During labor and delivery
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.
Measured: During delivery
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.
Measured: During labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start10 Jun 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, ObstetricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Lin Pan, National Taipei University of Nursing and Health Sciences
- Investigators
- Wan-Lin Pan, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663500
- Sponsor's protocol ID
- 2024E02
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07663500
- Acronym / sponsor ID
- 2024E02
- Keywords
- Integrated intrapartum supportive care, Spontaneous pushing, Immediate pushing, Low-dose epidural analgesia, Maternal mobility, Labor progression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Integrated Care with Spontaneous Pushing | Experimental | Behavioral: Integrated Care with Spontaneous Pushing GroupIntegrated Care with Spontaneous Pushing Group |
| Integrated Care with Immediate Pushing | Experimental | Behavioral: Integrated Care with Immediate PushingIntegrated Care with Immediate Pushing Group |
| Standard Routine Care | Active comparator | Behavioral: Standard Routine CareStandard Routine Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Care with Immediate PushingIntegrated 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. | Behavioural | Integrated Care with Immediate Pushing |
| Integrated Care with Spontaneous Pushing GroupParticipants 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. | Behavioural | Integrated Care with Spontaneous Pushing |
| Standard Routine CareParticipants 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. | Behavioural | Standard Routine Care |
Primary outcome
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.
3 secondary outcomes
Caesarean Section Rate
Time frame: During labor and delivery
Instrumental Vaginal Delivery Rate
Time frame: During delivery
Augmentation Rate
Time frame: During labor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wan-Lin Pan, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Care with Immediate Pushing, Integrated Care with Spontaneous Pushing Group and Standard Routine Care in people with Labor, Obstetric and Epidural Analgesia, Obstetric, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wan-Lin Pan, PhD (+886-2-2822-7101 ext. 7101, wanlimp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the first and second stages of labor (time frame: From the onset of active labor to the delivery of the fetus.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.