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Postpartum RecoveryNCT07582289

Labor Epidural Analgesia and Mother-Infant Bonding After Vaginal Delivery

An observational study of Postpartum Recovery and Mother-infant Bonding, run by Ataturk University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, women only
What is being tested?
Labor Epidural Analgesia
Type of treatment
Surgery or procedure
How many people
140 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2026to 17 Jun 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ayşenur Dostbil, Associate Professor contact

+90 533 367 66 96

adostbil@hotmail.com

Ayşe Ceren Hilal Güven, assistant doctor contact

+90 554 112 25 81

achg1995@gmail.com

Turkey (Türkiye)1 site
  • Ataturk University

    Erzurum, 25000

    Ayşe Ceren Hilal Güven, assistant doctor, 554-112-25-81, achg1995@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Labor Epidural Analgesia
Keywords
Labor Epidural Analgesia, Postpartum Bonding Questionnaire, PBQ, EPDS, STAIS-5, ObsQoR-10, Vaginal Birth, Postpartum Recovery, Maternal Bonding, Obstetric Anesthesia, Postpartum Anxiety, Postpartum Depression
Medical subject headings
Labor Pain, Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Labor Epidural AnalgesiaProcedure or surgery

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

Study groups in NCT07582289
Study groupRoleWhat they receive
Labor Epidural AnalgesiaWomen 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.
Receives: Procedure: Labor Epidural Analgesia
No Labor Epidural AnalgesiaWomen 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Mother-Infant Bonding Score

    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.

    Measured: 6 to 24 hours after vaginal delivery

Secondary outcomes (7)
  1. Postpartum Recovery Quality Score

    Postpartum recovery quality will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire. Higher scores indicate better postpartum recovery quality.

    Measured: 6 to 24 hours after vaginal delivery

  2. Postpartum Pain Intensity

    Postpartum pain intensity will be assessed using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS).

    Measured: 6 to 24 hours after vaginal delivery

  3. Postpartum Anxiety Level

    Postpartum anxiety level will be assessed using the STAIS-5 questionnaire.

    Measured: 6 to 24 hours after vaginal delivery

  4. Postpartum Depressive Symptoms

    Postpartum depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS).

    Measured: 6 to 24 hours after vaginal delivery

  5. Birth Satisfaction Score

    Birth satisfaction will be assessed using a 4-point Likert scale.

    Measured: 6 to 24 hours after vaginal delivery

  6. Mother-Infant Bonding at Postpartum Week 2

    Mother-infant bonding will be reassessed using the Postpartum Bonding Questionnaire (PBQ) during telephone follow-up at postpartum week 2.

    Measured: 2 weeks after vaginal delivery

  7. Postpartum Depressive Symptoms at Week 2

    Postpartum depressive symptoms will be reassessed using the Edinburgh Postnatal Depression Scale (EPDS) during telephone follow-up at postpartum week 2.

    Measured: 2 weeks after vaginal delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start15 May 2026 (estimated)
  3. Primary completion16 Jun 2029 (estimated)
  4. Study completion17 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07582289
Sponsor's protocol ID
B.30.2.ATA.0.01.00/234
Other IDs
2026/2
Status last verified
May 2026
First submitted
6 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly shared because of institutional and participant confidentiality policies.

Publications

  • 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.

    PubMed 39323115
  • 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.

    PubMed 3651732
  • 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.

    PubMed 15205733
  • 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

  • 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.

    PubMed 38518689
  • 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.

    PubMed 27321728
  • 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.

    PubMed 14992155
  • 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.

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

    PubMed 26526404
  • 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.

    PubMed 29781504
  • 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.

    PubMed 12011870
  • 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.

    PubMed 1764149
  • 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.

    PubMed 18194038
  • 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.

    PubMed 16673041
  • 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.

    PubMed 33345919

Questions about this trial

What is this clinical trial studying?

An observational study of Postpartum Recovery and Mother-infant Bonding, run by Ataturk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ayşenur Dostbil, Associate Professor (+90 533 367 66 96, adostbil@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mother-Infant Bonding Score (time frame: 6 to 24 hours after vaginal delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07582289, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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