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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02493192
Other study ID # V03_020911
Secondary ID
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


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
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