Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour
Information source: Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parturition; Humanizing Deliver; Labor Pain; Natural Childbirth; Labor Onset; First Labor Stage
Intervention: pethidine and haloperidol injection (Drug); birth ball (Other)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Hospital General Universitario Gregorio Marañon Overall contact: Julita Arranz, mcc, Phone: 620409480, Email: julitadelfin@gmail.com
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Primary outcome: pain
Secondary outcome: Baby´s apgar
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
Julita Arranz, mcc, Phone: 620409480, Email: julitadelfin@gmail.com
Hospital Universitario Gregorio Marañón, Madrid, Spain; Not yet recruiting Julita Fernández, Phone: 620409480, Email: julitadelfin@gmail.com
Additional Information
Related publications: 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. 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. Delgado-GarcÃa 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. 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. 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.
Starting date: July 2015
Last updated: July 8, 2015
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