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Low doses of Midazolam to reduce Anxiety in Pregnant Women undergoing Cesarean Section

Low doses of Midazolam to produce Anxiolysis in Pregnant Women undergoing Cesarean Section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-23jx2s
Enrollment
Unknown
Registered
2020-03-17
Start date
2017-12-06
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Anxiety

Interventions

Experimental group: 25 pregnant women indicated for cesarean section received 0.0125mg/kg of Midazolam IV, single dose, immediatly before the spinal anesthesia. Control group: 25 pregnant women indica
Drug
Behavioural

Sponsors

Pontifícia Universidade Católica de Campinas
Lead Sponsor
Pontifícia Universidade Católica de Campinas
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnant women indicated for cesarean section; aged between 18 And 40 years; physical status ASA II by the American Society of Anesthesiologists

Exclusion criteria

Exclusion criteria: Restriction of fetal development, fetal malformations, acute fetal distress, multiple pregnancy, acute pain, moderate to severe pneumopathies, psychopathologies that interfere with autonomy

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: reduction of preoperative anxiety after administering intravenous Midazolam, verified by Visual Analogue Scale for anxiety.;Outcome 1: was observed a reduction in anxiety of 13% in the experimental group while there was no change in the control group.

Secondary

MeasureTime frame
Expected outcome 2: no differences is expected between the groups regarding the newborn's vitality, verified by the Apgar scale at the first and fifth minutes after birth.;Outcome 2: no statistically significant differences were found in newborn’s vitality between the two groups.;Expected outcome 3: no difference is expected between the two groups in relation to the level of maternal consciouness, verified by the Ramsay scale.;Outcome 3: no statistically significant differences were found at the level of maternal consciousness between the two groups.;Expected outcome 4: no difference is expected between the two groups in relation to maternal recall of the moment of birth, 90 minutes after it, verified by standard question “You remember if your child was shown to you immediatly after the birth?”;Outcome 4: no statistically significant differences were found in relation to the maternal recall of the moment of the birth between the two groups.

Countries

Brazil

Contacts

Public ContactPedro Oliveira

Pontifícia Universidade Católica de Campinas

pscoliveira@gmail.com+55 19 3343-8600

Outcome results

None listed

Source: REBEC (via WHO ICTRP)