Labor Epidural Analgesia and Mother-Infant Bonding After Vaginal Delivery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorAtaturk University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants aged 18 to 40 years
Term singleton pregnancy (≥37 weeks)
Planned vaginal delivery
ASA physical status II
Disqualifiers
Contraindications to epidural analgesia including coagulopathy, anticoagulant use, infection, or increased intracranial pressure
Cesarean delivery
High-risk pregnancy
Neonatal intensive care unit requirement
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Labor Epidural Analgesia
Procedure/SurgeryEpidural analgesia administered during labor as part of routine clinical care for pain management during vaginal delivery.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Labor Epidural Analgesia1 intervention
Group B: No Labor Epidural Analgesia0 interventions
Trial outcomes
Primary outcomes
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.
Time frame
6 to 24 hours after vaginal deliverySecondary outcomes
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.
Time frame
6 to 24 hours after vaginal delivery2
Postpartum Pain Intensity
Postpartum pain intensity will be assessed using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS).
Time frame
6 to 24 hours after vaginal delivery3
Postpartum Anxiety Level
Postpartum anxiety level will be assessed using the STAIS-5 questionnaire.
Time frame
6 to 24 hours after vaginal delivery4
Postpartum Depressive Symptoms
Postpartum depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS).
Time frame
6 to 24 hours after vaginal deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: