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

Labor Pain Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02493192
• Other study ID #: V03_020911
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 23, 2015
• Last updated: July 8, 2015
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Julita Arranz, mcc
• Phone: 620409480
• Email: julitadelfin[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• pethidine and haloperidol injection

Other:
• birth ball

Locations

Country	Name	City	State
Spain	Hospital Universitario Gregorio Marañón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Delgado-García BE, Orts-Cortés MI, Poveda-Bernabeu A, Caballero-Pérez 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	24 months	Yes