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

Hospital General Universitario Gregorio Marañon

Status and phase: Unknown; Phase 4

Conditions: Labor Pain; Humanizing Deliver; Natural Childbirth; Parturition; First Labor Stage; Labor Onset

Treatments: Drug: pethidine and haloperidol injection; Other: birth ball

Study type: Interventional

Funder types: Other

Identifiers

NCT02493192

V03_020911

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Meperidine

Active Comparator group

Description:

Use pethidine and haloperidol injection as a pain relief.

Treatment:

Drug: pethidine and haloperidol injection

birth ball

Experimental group

Description:

Use birth ball as a pain relief.

Treatment:

Other: birth ball