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Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour

Sponsor
Hospital General Universitario Gregorio Marañon (Other)
Overall Status
Unknown status
CT.gov ID
NCT02493192
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
17.1
Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study was performed at Gregorio Marañón Hospital birth centre. A Randomised Clinical Trial comparing the two methods of pain relief in the first time of labour was carried out. In this study, 110 women in the first stage of labour were allocated in two study groups by a randomised block design. One of them used the birth ball as a pain relief method,and the other one used pethidine and haloperidol injection.

Condition or Disease Intervention/Treatment Phase
  • Drug: pethidine and haloperidol injection
  • Other: birth ball
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Study Start Date :
Jul 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Meperidine

Use pethidine and haloperidol injection as a pain relief.

Drug: pethidine and haloperidol injection
Other Names:
  • meperidine and haloperidol injection

    		•
    Experimental: birth ball

    Use birth ball as a pain relief.

    Other: birth ball
    Other Names:
  • fit ball, swiss ball

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pain [24 months]

      We use a numeric scale, since 0 ( no pain) to 10 (the greatest pain), to measure this item. We use it with women in the first stage of labour, with labor pain

    Secondary Outcome Measures

    1. Baby´s apgar [24 months]

      We use the apgar Test to measure this item. Since 0 to 10.We use it after birth, with babies of women who are in our study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • healthy pregnant women

    • women in the first stage of labour or women at induction of labour

    • fetal head in pelvis or whole amniotic membranes

    • must be able to understand spanish

    Exclusion Criteria:

    • intrapartum meconium

    • needed of continuous fetal monitoring

    • suspecte/compromise fetal wellbeing

    • morbidly obese women

    • unaccompanied women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario Gregorio Marañón Madrid Spain

    Sponsors and Collaborators

    • Hospital General Universitario Gregorio Marañon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Julia Fernandez, Julita Fernández Arranz, Hospital General Universitario Gregorio Marañon
    ClinicalTrials.gov Identifier:
    NCT02493192
    Other Study ID Numbers:
    • V03_020911
    First Posted:
    Jul 9, 2015
    Last Update Posted:
    Jul 9, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Julia Fernandez, Julita Fernández Arranz, Hospital General Universitario Gregorio Marañon
    Parturition
    Humanizing Deliver
    Labor Pain
    Natural Childbirth
    Labor Onset
    First Labor Stage
    Birth ball
    meperidine
    pethidine
    Additional relevant MeSH terms:
    Labor Pain
    Meperidine
    Haloperidol
    Haloperidol decanoate

    Study Results

    No Results Posted as of Jul 9, 2015