Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Labor Epidural Analgesia and Mother-Infant Bonding After Vaginal Delivery

30. mai 2026 oppdatert av: Aysenur Dostbil, Ataturk University

Association Between Postpartum Recovery Quality Measured by ObsQoR-10 and Mother-Infant Bonding After Vaginal Delivery: The Role of Labor Epidural Analgesia

This prospective observational cohort study aims to evaluate the association between postpartum recovery quality and mother-infant bonding in women undergoing vaginal delivery. Postpartum recovery quality will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire, and mother-infant bonding will be evaluated using the Postpartum Bonding Questionnaire (PBQ).

Participants will be grouped according to routine clinical labor analgesia preference: women receiving labor epidural analgesia and women not receiving epidural analgesia. Additional assessments will include postpartum pain intensity, anxiety, depressive symptoms, and birth satisfaction.

Baseline psychological assessments will be performed before delivery. The primary postpartum evaluation will be conducted between 6 and 24 hours after delivery. Exploratory follow-up assessments will be performed by telephone during postpartum week 2.

The study aims to better understand the relationship between labor analgesia, postpartum recovery, and early mother-infant bonding outcomes after vaginal delivery.

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

This single-center prospective observational cohort study will be conducted at Atatürk University Research Hospital. The study will include term pregnant women planning vaginal delivery.

Participants will be classified into two cohorts according to routine clinical labor analgesia preference:

Women receiving labor epidural analgesia Women not receiving labor epidural analgesia No experimental intervention will be applied as part of the study protocol. Epidural analgesia, when used, will be administered according to routine clinical practice.

Primary Objective:

To evaluate the association between postpartum recovery quality measured using the ObsQoR-10 questionnaire and mother-infant bonding measured using the Postpartum Bonding Questionnaire (PBQ), and to investigate the role of labor epidural analgesia in this relationship.

Secondary Objectives:

To compare postpartum recovery quality between cohorts To compare mother-infant bonding outcomes between cohorts To evaluate postpartum pain, anxiety, depressive symptoms, and birth satisfaction To assess the association between obstetric variables and postpartum recovery outcomes

Assessments:

Prepartum:

STAIS-5 EPDS

Early postpartum period (6-24 hours):

ObsQoR-10 PBQ STAIS-5 EPDS Pain score (VAS/NRS) Birth satisfaction Likert scale

Postpartum week 2:

PBQ EPDS Participants will provide written informed consent before enrollment. All collected data will be anonymized and analyzed confidentially.

Studietype

Observasjonsmessig

Registrering (Antatt)

140

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Ayşenur Dostbil, Associate Professor
  • Telefonnummer: +90 533 367 66 96
  • E-post: adostbil@hotmail.com

Studer Kontakt Backup

  • Navn: Ayşe Ceren Hilal Güven, assistant doctor
  • Telefonnummer: +90 554 112 25 81
  • E-post: achg1995@gmail.com

Studiesteder

      • Erzurum, Tyrkia (Türkiye), 25000
        • Ataturk University
        • Ta kontakt med:
          • Ayşe Ceren Hilal Güven, assistant doctor
          • Telefonnummer: 554-112-25-81
          • E-post: achg1995@gmail.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Women with term singleton pregnancy planning vaginal delivery at Atatürk University Research Hospital will be enrolled. Participants will be grouped according to routine clinical labor epidural analgesia preference.

Beskrivelse

Inclusion Criteria:

  • Female participants aged 18 to 40 years
  • Term singleton pregnancy (≥37 weeks)
  • Planned vaginal delivery
  • ASA physical status II
  • Ability to understand Turkish
  • Written informed consent

Exclusion Criteria:

  • Contraindications to epidural analgesia including coagulopathy, anticoagulant use, infection, or increased intracranial pressure
  • Cesarean delivery
  • High-risk pregnancy
  • Neonatal intensive care unit requirement
  • Major depressive disorder
  • Anxiety disorder
  • Current psychotropic medication use

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Labor Epidural Analgesia
Women undergoing vaginal delivery with labor epidural analgesia as part of routine clinical care. Participants will undergo postpartum recovery, mother-infant bonding, anxiety, depression, pain, and birth satisfaction assessments during the postpartum period.
Epidural analgesia administered during labor as part of routine clinical care for pain management during vaginal delivery.
No Labor Epidural Analgesia
Women undergoing vaginal delivery without labor epidural analgesia as part of routine clinical care. Participants will be evaluated for postpartum recovery quality, mother-infant bonding, anxiety, depressive symptoms, pain intensity, and birth satisfaction during the postpartum period.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mother-Infant Bonding Score
Tidsramme: 6 to 24 hours after vaginal delivery
Mother-infant bonding will be assessed using the Postpartum Bonding Questionnaire (PBQ), a 25-item scale with a total score ranging from 0 to 125. Lower scores indicate better mother-infant bonding, while higher scores indicate poorer bonding.
6 to 24 hours after vaginal delivery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postpartum Recovery Quality Score
Tidsramme: 6 to 24 hours after vaginal delivery
Postpartum recovery quality will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire. Higher scores indicate better postpartum recovery quality.
6 to 24 hours after vaginal delivery
Postpartum Pain Intensity
Tidsramme: 6 to 24 hours after vaginal delivery
Postpartum pain intensity will be assessed using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS).
6 to 24 hours after vaginal delivery
Postpartum Anxiety Level
Tidsramme: 6 to 24 hours after vaginal delivery
Postpartum anxiety level will be assessed using the STAIS-5 questionnaire.
6 to 24 hours after vaginal delivery
Postpartum Depressive Symptoms
Tidsramme: 6 to 24 hours after vaginal delivery
Postpartum depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS).
6 to 24 hours after vaginal delivery
Birth Satisfaction Score
Tidsramme: 6 to 24 hours after vaginal delivery
Birth satisfaction will be assessed using a 4-point Likert scale.
6 to 24 hours after vaginal delivery
Mother-Infant Bonding at Postpartum Week 2
Tidsramme: 2 weeks after vaginal delivery
Mother-infant bonding will be reassessed using the Postpartum Bonding Questionnaire (PBQ) during telephone follow-up at postpartum week 2.
2 weeks after vaginal delivery
Postpartum Depressive Symptoms at Week 2
Tidsramme: 2 weeks after vaginal delivery
Postpartum depressive symptoms will be reassessed using the Edinburgh Postnatal Depression Scale (EPDS) during telephone follow-up at postpartum week 2.
2 weeks after vaginal delivery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Ayşe Ceren Hilal Güven, assistant doctor, Ataturk University Department of Anesthesiology and Reanimation

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. mai 2026

Primær fullføring (Antatt)

16. juni 2029

Studiet fullført (Antatt)

17. juni 2029

Datoer for studieregistrering

Først innsendt

6. mai 2026

Først innsendt som oppfylte QC-kriteriene

6. mai 2026

Først lagt ut (Faktiske)

12. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be publicly shared because of institutional and participant confidentiality policies.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere