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Trial · NCT03167905

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe incidence of major postnatal depression in both groups6-10 weeks after deliveryEdinburgh Postnatal Depression Scale (EPDS) score\>=13
PrimaryThe incidence of (clinically significant, probable) postnatal depression in both groups6-10 weeks after deliveryEdinburgh Postnatal Depression Scale (EPDS) score\>=10
SecondaryThe incidence of acquiring post-delivery persistent pain in both groups6-10 weeks after deliveryPain score\>3 in the perineal, surgical scar or abdomen region that lasts for at least 6 weeks post-delivery
SecondaryPain vulnerability in both groups (1)Upon recruitment until 6-10 weeks after deliveryAssessment via Pain Catastrophizing Scale (PCS) questionnaire before and after delivery
SecondaryPain vulnerability in both groups (2)Upon recruitment until 6-10 weeks after deliveryAssessment via Central Sensitisation Inventory (CSI) questionnaire before and after delivery
SecondaryPain vulnerability in both groups (3)Upon recruitment till end of first stage of labor (1 day)Assessment via Angle Labor Pain Questionnaire (A-LPQ) during first stage of labor when the participants experience labor pain
SecondaryPsychological vulnerability in both groups (1)Upon recruitment until 5 days after deliveryAssessment via Fear-Avoidance Components Scale (FACS) questionnaire before delivery
SecondaryPsychological vulnerability in both groups (2)Upon recruitment until 5 days after deliveryAssessment via State Trait Anxiety Inventory (STAI) questionnaire before delivery
SecondaryPsychological vulnerability in both groups (3)Upon recruitment until 5 days after deliveryAssessment via Perceived Stress Scale (PSS) questionnaire before delivery
SecondaryPain severity in both groupsDuring labour till one day after deliveryPain score\>3 during labour
SecondaryPreferences for labor analgesiaPrior to labor and delivery
Recruited patients will be administered a survey on Discrete Choice Experiment (DCE) and other questions on their preferences for labor analgesia. For DCE, nine tasks will be included in which parturients will choose one of four hypothetical forms of labor analgesia: 1) epidural analgesia, 2) pethidine, 3) Entonox (nitrous oxide-oxygen mixture), and 4) no labor analgesia, which varies with regards to six attributes: 1) pain intensity following treatment, 2) duration of second stage of labor, 3) risk of instrumental delivery, 4) risk of back pain, 5) risk of permanent nerve injury, and 6) out-of-pocket cost.
SecondaryPreferences for epidural analgesiaPrior to labor and delivery
Recruited patients will be administered a survey on their preferences and opinions on epidural analgesia, including their concerns on possible risk of epidural analgesia e.g. instrumental delivery, prolonged duration of second stage of labor, back pain etc.
SecondaryChinese version of Angle Labor Pain Questionnaire (A-LPQ)Upon recruitment till end of first stage of labor (1 day)
Assessment via Angle Labor Pain Questionnaire (A-LPQ) during first stage of labor when the participants experience labor pain. The tool comprises 22 items divided into five subscales on the childbirth pain experience: the enormity of the pain, the fear and anxiety, uterine contraction pain, birthing pain, and the back pain/ long haul. Each item is scaled from 0 to 10, implying a range from non to worst possible or extremely (where applicable), and therefore has a total score ranged from 0 to 220. The higher the score, the greater the labor pain.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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