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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02493192
Enrollment
110
Registered
2015-07-09
Start date
2015-07-31
Completion date
2016-12-31
Last updated
2015-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Parturition, Humanizing Deliver, Labor Pain, Natural Childbirth, Labor Onset, First Labor Stage, Birth ball, meperidine, pethidine

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.

Interventions

DRUGpethidine and haloperidol injection

Sponsors

Hospital General Universitario Gregorio Marañon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pain24 monthsWe 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

MeasureTime frameDescription
Baby´s apgar24 monthsWe 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.

Countries

Spain

Contacts

Primary ContactJulita Arranz, mcc
julitadelfin@gmail.com620409480

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026