- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07663500
Integrated Intrapartum Supportive Care and Pushing Strategies in Women Receiving Low-Dose Epidural Analgesia
Integrated Intrapartum Supportive Care Combined With Different Pushing Strategies Among Women Receiving Low-Dose Epidural Analgesia: A Three-Arm Non-Randomized Quasi-Experimental Study
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wan-Lin Pan, PhD
- Phone Number: +886-2-2822-7101 ext. 7101
- Email: wanlimp@gmail.com
Study Locations
-
-
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Taipei, Taiwan, 10556
- Recruiting
- Taiwan Adventist Hospital
-
Contact:
- Wan-Lin Pan
- Phone Number: 0933710737
- Email: wanlimp@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Integrated Care with Spontaneous Pushing
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.
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|
Experimental: Integrated Care with Immediate Pushing
Integrated Care with Immediate Pushing Group
|
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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From the onset of active labor to the delivery of the fetus.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During labor and delivery
|
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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.
|
During delivery
|
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Augmentation Rate
Time Frame: During labor
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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.
|
During labor
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wan-Lin Pan, PhD, National Taipei University of Nursing and Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024E02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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