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

NCT ID: NCT02493192

Last Updated: 2015-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parturition Humanizing Deliver Labor Pain Natural Childbirth Labor Onset First Labor Stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Meperidine

Use pethidine and haloperidol injection as a pain relief.

Group Type ACTIVE_COMPARATOR

pethidine and haloperidol injection

Intervention Type DRUG

birth ball

Use birth ball as a pain relief.

Group Type EXPERIMENTAL

birth ball

Intervention Type OTHER

Interventions

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pethidine and haloperidol injection

Intervention Type DRUG

birth ball

Intervention Type OTHER

Other Intervention Names

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meperidine and haloperidol injection fit ball, swiss ball

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role lead

Responsible Party

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Julia Fernandez

Julita Fernández Arranz

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Gregorio Marañón

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Central Contacts

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Julita Arranz, mcc

Role: CONTACT

620409480

Facility Contacts

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Julita Fernández

Role: primary

620409480

References

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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.

Reference Type BACKGROUND
PMID: 23878201 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23252582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21885314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21459499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21429078 (View on PubMed)

Other Identifiers

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V03_020911

Identifier Type: -

Identifier Source: org_study_id

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