NCT02493192

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 9, 2015

Status Verified

June 1, 2015

Enrollment Period

5 months

First QC Date

June 23, 2015

Last Update Submit

July 8, 2015

Conditions

ParturitionHumanizing DeliverLabor PainNatural ChildbirthLabor OnsetFirst Labor Stage

Keywords

ParturitionHumanizing DeliverLabor PainNatural ChildbirthLabor OnsetFirst Labor StageBirth ballmeperidinepethidine

Outcome Measures

Primary Outcomes (1)

  • 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

    24 months

Secondary Outcomes (1)

  • Baby´s apgar

    24 months

Study Arms (2)

Meperidine

ACTIVE COMPARATOR

Use pethidine and haloperidol injection as a pain relief.

Drug: pethidine and haloperidol injection

birth ball

EXPERIMENTAL

Use birth ball as a pain relief.

Other: birth ball

Interventions

pethidine and haloperidol injectionDRUG
Also known as: meperidine and haloperidol injection
Meperidine
birth ballOTHER
Also known as: fit ball, swiss ball
birth ball

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • intrapartum meconium
  • needed of continuous fetal monitoring
  • suspecte/compromise fetal wellbeing
  • morbidly obese women
  • unaccompanied women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Gregorio Marañón

Madrid, Madrid, Spain

Location

Related Publications (5)

  • 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.

    PMID: 23878201BACKGROUND

  • 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.

    PMID: 23252582BACKGROUND

  • 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.

    PMID: 21885314BACKGROUND

  • 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.

    PMID: 21459499BACKGROUND

  • 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.

    PMID: 21429078BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

MeperidineHaloperidol

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingButyrophenonesKetonesOrganic Chemicals

Central Study Contacts

Julita Arranz, mcc

CONTACT

620409480julitadelfin@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Julita Fernández Arranz

Study Record Dates

First Submitted

June 23, 2015

First Posted

July 9, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

July 9, 2015

Record last verified: 2015-06

Locations

ES(1)