Integrated Intrapartum Supportive Care and Pushing Strategies in Women Receiving Low-Dose Epidural Analgesia
17 juni 2026 bijgewerkt door: Wan-Lin Pan, National Taipei University of Nursing and Health Sciences
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.
Studie Overzicht
Toestand
Werving
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
159
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Wan-Lin Pan, PhD
- Telefoonnummer: +886-2-2822-7101 ext. 7101
- E-mail: wanlimp@gmail.com
Studie Locaties
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Taipei, Taiwan, 10556
- Werving
- Taiwan Adventist Hospital
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Contact:
- Wan-Lin Pan
- Telefoonnummer: 0933710737
- E-mail: wanlimp@gmail.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Integrated Care with Spontaneous Pushing
Integrated Care with Spontaneous Pushing Group
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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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Experimenteel: Integrated Care with Immediate Pushing
Integrated Care with Immediate Pushing Group
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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.
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Actieve vergelijker: Standard Routine Care
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Duration of the first and second stages of labor
Tijdsspanne: From the onset of active labor to the delivery of the fetus.
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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.
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From the onset of active labor to the delivery of the fetus.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Caesarean Section Rate
Tijdsspanne: During labor and delivery
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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.
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During labor and delivery
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Instrumental Vaginal Delivery Rate
Tijdsspanne: During delivery
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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.
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During delivery
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Augmentation Rate
Tijdsspanne: 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.
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During labor
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Wan-Lin Pan, PhD, National Taipei University of Nursing and Health Sciences
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 juni 2025
Primaire voltooiing (Geschat)
31 juli 2026
Studie voltooiing (Geschat)
31 juli 2026
Studieregistratiedata
Eerst ingediend
17 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
17 juni 2026
Eerst geplaatst (Werkelijk)
23 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
23 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
17 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 2024E02
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
This study does not plan to share individual participant data.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .