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

Phase 4

• Conditions: Parturition; First Labor Stage; Natural Childbirth; Labor Onset; Labor Pain; Humanizing Deliver
• Interventions: Other: birth ball; Drug: pethidine and haloperidol injection

• Registration Number: NCT02493192
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-06
• Study First Submitted: 2015-06-23
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-08
• Last Update Submitted: 2015-07-08
• Study First Posted: 2015-07-09
• Last Update Posted: 2015-07-09
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
birth ball	birth ball	Use birth ball as a pain relief.
Meperidine	pethidine and haloperidol injection	Use pethidine and haloperidol injection as a pain relief.

Primary Outcome Measures

Name	Time	Method
pain	24 months	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

Secondary Outcome Measures

Name	Time	Method
Baby´s apgar	24 months	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.

Trial Locations

Locations (1)

Hospital Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain