- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07582289
Labor Epidural Analgesia and Mother-Infant Bonding After Vaginal Delivery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ayşenur Dostbil, Associate Professor
- Phone Number: +90 533 367 66 96
- Email: adostbil@hotmail.com
Study Contact Backup
- Name: Ayşe Ceren Hilal Güven, assistant doctor
- Phone Number: +90 554 112 25 81
- Email: achg1995@gmail.com
Study Locations
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Erzurum, Turkey (Türkiye), 25000
- Ataturk University
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Contact:
- Ayşe Ceren Hilal Güven, assistant doctor
- Phone Number: 554-112-25-81
- Email: achg1995@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mother-Infant Bonding Score
Time Frame: 6 to 24 hours after vaginal delivery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum Recovery Quality Score
Time Frame: 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.
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6 to 24 hours after vaginal delivery
|
|
Postpartum Pain Intensity
Time Frame: 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
Time Frame: 6 to 24 hours after vaginal delivery
|
Postpartum anxiety level will be assessed using the STAIS-5 questionnaire.
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6 to 24 hours after vaginal delivery
|
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Postpartum Depressive Symptoms
Time Frame: 6 to 24 hours after vaginal delivery
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Postpartum depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS).
|
6 to 24 hours after vaginal delivery
|
|
Birth Satisfaction Score
Time Frame: 6 to 24 hours after vaginal delivery
|
Birth satisfaction will be assessed using a 4-point Likert scale.
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6 to 24 hours after vaginal delivery
|
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Mother-Infant Bonding at Postpartum Week 2
Time Frame: 2 weeks after vaginal delivery
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Mother-infant bonding will be reassessed using the Postpartum Bonding Questionnaire (PBQ) during telephone follow-up at postpartum week 2.
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2 weeks after vaginal delivery
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Postpartum Depressive Symptoms at Week 2
Time Frame: 2 weeks after vaginal delivery
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Postpartum depressive symptoms will be reassessed using the Edinburgh Postnatal Depression Scale (EPDS) during telephone follow-up at postpartum week 2.
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2 weeks after vaginal delivery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ayşe Ceren Hilal Güven, assistant doctor, Ataturk University Department of Anesthesiology and Reanimation
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Labor S, Maguire S. The Pain of Labour. Rev Pain. 2008 Dec;2(2):15-9. doi: 10.1177/204946370800200205.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ATA.0.01.00/234
- 2026/2 (Other Identifier: Atatürk University Clinical Research Ethics Committee)
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
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