NCT07582289

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
38mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jun 2029

First Submitted

Initial submission to the registry

May 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2029

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2029

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

3.1 years

First QC Date

May 6, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

Labor Epidural AnalgesiaPostpartum Bonding QuestionnairePBQEPDSSTAIS-5ObsQoR-10Vaginal BirthPostpartum RecoveryMaternal BondingObstetric AnesthesiaPostpartum AnxietyPostpartum Depression

Outcome Measures

Primary Outcomes (1)

  • Mother-Infant Bonding Score

    Mother-infant bonding will be assessed using the Postpartum Bonding Questionnaire (PBQ). Lower PBQ scores indicate better mother-infant bonding.

    6 to 24 hours after vaginal delivery

Secondary Outcomes (7)

  • Postpartum Recovery Quality Score

    6 to 24 hours after vaginal delivery

  • Postpartum Pain Intensity

    6 to 24 hours after vaginal delivery

  • Postpartum Anxiety Level

    6 to 24 hours after vaginal delivery

  • Postpartum Depressive Symptoms

    6 to 24 hours after vaginal delivery

  • Birth Satisfaction Score

    6 to 24 hours after vaginal delivery

  • +2 more secondary outcomes

Study Arms (2)

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.

Procedure: Labor Epidural Analgesia

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.

Interventions

Epidural analgesia administered during labor as part of routine clinical care for pain management during vaginal delivery.

Labor Epidural Analgesia

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale participants with term singleton pregnancy planning vaginal delivery are eligible for participation in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

Location

Related Publications (17)

  • Doner S, Efe YS, Elmali F. Turkish adaptation of the state-trait anxiety inventory short version (STAIS-5, STAIT-5). Int J Nurs Pract. 2024 Dec;30(6):e13304. doi: 10.1111/ijn.13304. Epub 2024 Sep 25.

    PMID: 39323115BACKGROUND
  • Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

    PMID: 3651732BACKGROUND
  • Aydin N, Inandi T, Yigit A, Hodoglugil NN. Validation of the Turkish version of the Edinburgh Postnatal Depression Scale among women within their first postpartum year. Soc Psychiatry Psychiatr Epidemiol. 2004 Jun;39(6):483-6. doi: 10.1007/s00127-004-0770-4.

    PMID: 15205733BACKGROUND
  • Brockington IF, Oates J, George S, et al. A screening questionnaire for mother-infant bonding disorders. Archives of Women's Mental Health. 2001;3(4):133-140. doi:10.1007/s007370170010

    BACKGROUND
  • Dissiz M, Bayri Bingol F, Demirgoz Bal M, Karacam Yilmaz ZD, Karakoc A, Bilgin Z. The Turkish version of the Postpartum Bonding Questionnaire (PBQ): Examination of the validity and reliability and scale structure. J Pediatr Nurs. 2024 Jul-Aug;77:131-139. doi: 10.1016/j.pedn.2024.03.012. Epub 2024 Mar 21.

    PMID: 38518689BACKGROUND
  • Bell AF, Andersson E. The birth experience and women's postnatal depression: A systematic review. Midwifery. 2016 Aug;39:112-23. doi: 10.1016/j.midw.2016.04.014. Epub 2016 May 7.

    PMID: 27321728BACKGROUND
  • Waldenstrom U. Women's memory of childbirth at two months and one year after the birth. Birth. 2003 Dec;30(4):248-54. doi: 10.1046/j.1523-536x.2003.00254.x.

    PMID: 14992155BACKGROUND
  • Hodnett ED. Pain and women's satisfaction with the experience of childbirth: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S160-72. doi: 10.1067/mob.2002.121141.

    PMID: 12011880BACKGROUND
  • Labor S, Maguire S. The Pain of Labour. Rev Pain. 2008 Dec;2(2):15-9. doi: 10.1177/204946370800200205.

    PMID: 26526404BACKGROUND
  • Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.

    PMID: 29781504BACKGROUND
  • Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.

    PMID: 12011870BACKGROUND
  • Simkin P. Just another day in a woman's life? Women's long-term perceptions of their first birth experience. Part I. Birth. 1991 Dec;18(4):203-10. doi: 10.1111/j.1523-536x.1991.tb00103.x.

    PMID: 1764149BACKGROUND
  • Feldman R. Mother-infant synchrony and the development of moral orientation in childhood and adolescence: direct and indirect mechanisms of developmental continuity. Am J Orthopsychiatry. 2007 Oct;77(4):582-97. doi: 10.1037/0002-9432.77.4.582.

    PMID: 18194038BACKGROUND
  • Brockington IF, Fraser C, Wilson D. The Postpartum Bonding Questionnaire: a validation. Arch Womens Ment Health. 2006 Sep;9(5):233-42. doi: 10.1007/s00737-006-0132-1. Epub 2006 May 4.

    PMID: 16673041BACKGROUND
  • Sultan P, Kamath N, Carvalho B, Bansal P, Elkhateb R, Dougan S, Whittington J, Guo N, El-Sayed Y, Mhyre J, Sharawi N. Evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery-10 patient-reported outcome measure: a single-center observational study. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100202. doi: 10.1016/j.ajogmf.2020.100202. Epub 2020 Aug 17.

    PMID: 33345919BACKGROUND
  • Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.

    PMID: 30579408BACKGROUND
  • Bowyer A, Royse C. The importance of postoperative quality of recovery: influences, assessment, and clinical and prognostic implications. Can J Anaesth. 2016 Feb;63(2):176-83. doi: 10.1007/s12630-015-0508-7.

    PMID: 26475163BACKGROUND

MeSH Terms

Conditions

Labor PainDepression, Postpartum

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Ayşe Ceren Hilal Güven, assistant doctor

    Ataturk University Department of Anesthesiology and Reanimation

    STUDY CHAIR

Central Study Contacts

Ayşenur Dostbil, Associate Professor

CONTACT

Ayşe Ceren Hilal Güven, assistant doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor as the Principal Investigator

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 12, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

June 16, 2029

Study Completion (Estimated)

June 17, 2029

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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

Locations