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

Primary Purpose

Parturition, Humanizing Deliver, Labor Pain

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
pethidine and haloperidol injection
birth ball
Sponsored by
Hospital General Universitario Gregorio Marañon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parturition focused on measuring Parturition, Humanizing Deliver, Labor Pain, Natural Childbirth, Labor Onset, First Labor Stage, Birth ball, meperidine, pethidine

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario Gregorio Marañón

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Meperidine

birth ball

Arm Description

Use pethidine and haloperidol injection as a pain relief.

Use birth ball as a pain relief.

Outcomes

Primary Outcome Measures

pain
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

Baby´s apgar
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.

Full Information

First Posted
June 23, 2015
Last Updated
July 8, 2015
Sponsor
Hospital General Universitario Gregorio Marañon
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1. Study Identification

Unique Protocol Identification Number
NCT02493192
Brief Title
Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Gregorio Marañon

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parturition, Humanizing Deliver, Labor Pain, Natural Childbirth, Labor Onset, First Labor Stage
Keywords
Parturition, Humanizing Deliver, Labor Pain, Natural Childbirth, Labor Onset, First Labor Stage, Birth ball, meperidine, pethidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meperidine
Arm Type
Active Comparator
Arm Description
Use pethidine and haloperidol injection as a pain relief.
Arm Title
birth ball
Arm Type
Experimental
Arm Description
Use birth ball as a pain relief.
Intervention Type
Drug
Intervention Name(s)
pethidine and haloperidol injection
Other Intervention Name(s)
meperidine and haloperidol injection
Intervention Type
Other
Intervention Name(s)
birth ball
Other Intervention Name(s)
fit ball, swiss ball
Primary Outcome Measure Information:
Title
pain
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Baby´s apgar
Description
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.
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julita Arranz, mcc
Phone
620409480
Email
julitadelfin@gmail.com
Facility Information:
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julita Fernández
Phone
620409480
Email
julitadelfin@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
23878201
Citation
Leung RW, Li JF, Leung MK, Fung BK, Fung LC, Tai SM, Sing C, Leung WC. Efficacy of birth ball exercises on labour pain management. Hong Kong Med J. 2013 Oct;19(5):393-9. doi: 10.12809/hkmj133921. Epub 2013 Jul 22.
Results Reference
background
PubMed Identifier
23252582
Citation
Schult TM, Awosika ER, Schmunk SK, Hodgson MJ, Heymach BL, Parker CD. Sitting on stability balls: biomechanics evaluation in a workplace setting. J Occup Environ Hyg. 2013;10(2):55-63. doi: 10.1080/15459624.2012.748324.
Results Reference
background
PubMed Identifier
21885314
Citation
Delgado-Garcia BE, Orts-Cortes MI, Poveda-Bernabeu A, Caballero-Perez P. [Randomised controlled clinical trial to determine the effects of the use of birth balls during labour]. Enferm Clin. 2012 Jan-Feb;22(1):35-40. doi: 10.1016/j.enfcli.2011.07.001. Epub 2011 Aug 31. Spanish.
Results Reference
background
PubMed Identifier
21459499
Citation
Gau ML, Chang CY, Tian SH, Lin KC. Effects of birth ball exercise on pain and self-efficacy during childbirth: a randomised controlled trial in Taiwan. Midwifery. 2011 Dec;27(6):e293-300. doi: 10.1016/j.midw.2011.02.004. Epub 2011 Apr 3.
Results Reference
background
PubMed Identifier
21429078
Citation
Taavoni S, Abdolahian S, Haghani H, Neysani L. Effect of birth ball usage on pain in the active phase of labor: a randomized controlled trial. J Midwifery Womens Health. 2011 Mar-Apr;56(2):137-40. doi: 10.1111/j.1542-2011.2010.00013.x. Epub 2011 Feb 28.
Results Reference
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Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour

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