Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001326381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
23/02/2026
Date registered
Help: Date registered
3/11/2026
Date last updated
Help: Date last updated
3/11/2026
Date data sharing statement initially provided
Help: Data sharing statement date
3/11/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Pre-medication with Midazolam Prior to Caesarean Section on Mothers' Anxiety and
APGAR Score of Neonates
Scientific title
Effect of Pre-medication with Midazolam Prior to Caesarean Section on Mothers' Anxiety and APGAR Score of Neonates
Additional trial identifiers [1] 316609 0
Nil
Universal Trial Number (UTN)
Trial acronym
CALM-MOM Trial Caesarean Anxiety Lowering with Midazolam in Mothers
Related trial records

Health condition
Health condition(s) studied:
Maternal preoperative anxiety 340811 0
Condition category
Condition code
Mental Health 336980 336980 0 0
Anxiety
Reproductive Health and Childbirth 337924 337924 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Brief description of study interventions
A total of 80 patients will take part in this study, divided into two groups containing 40 patients each. To make sure the results are fair, participants will be assigned to one of the two groups by chance. Each group will have 40 participants and will receive single intravenous dose of midazolam 0.02-0.025 mg/kg or saline solution of equal amount 5-30 minutes before elective cesarean section by the attending anesthetist. One group will receive midazolam and the second group will receive saline solution. Continuous standard monitoring of the patients will be done throughout the procedure.
Intervention code [1] 333293 0
Treatment: Drugs
Intervention code [2] 334016 0
Behaviour
Intervention code [3] 334017 0
Prevention
Description of the comparator or control
Participants in the control group will receive single intravenous dose of 2ml normal saline (placebo) administered 5–30 minutes prior to elective caesarean section under spinal anesthesia by the attending anesthetist. All other perioperative care, monitoring, and management will be identical to the intervention group.
Control group
Placebo

Outcomes
Primary outcome [1] 344501 0
Maternal Anxiety Level Before Spinal Anesthesia
Timepoint [1] 344501 0
Immediately before administration of midazolam/placebo and immediately prior to spinal anesthesia (approximately 45-60 mins post-administration of midazolam/placebo).
Secondary outcome [1] 458068 0
Neonatal Apgar Score at 1 minute and 5 minutes will be assessed as a composite secondary outcome.
Timepoint [1] 458068 0
at 1 and 5 minutes after delivery of baby
Secondary outcome [2] 461440 0
Incidence of side effects of midazolam( nausea, vomiting, dizziness) will also be assessed
Timepoint [2] 461440 0
After administration of midazolam to about 45-60 minutes during the procedure.
Secondary outcome [3] 461441 0
Maternal hemodynamics heart rate ,blood pressure, saturation and sedation level measured throughout the procedure as a composite secondary outcome
Timepoint [3] 461441 0
From the start of procedure to the end of cesarean section about 45-60 minutes

Eligibility
Key inclusion criteria
1. ASA class II and III patients.
2. Female patients of age 18-45 years undergoing elective C-section
3. Patient willing to take part in study.
4. Patient with Pregnancy Induced hypertension
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Healthy volunteers
No
Key exclusion criteria
1. Non-elective cases.
2. Patients with multiple or preterm pregnancies.
3. Cases involving known fetal abnormalities or intrauterine growth restriction (less than 2500 grams).
4. Conditions that could influence acid-base balance.
5. Patients diagnosed with diabetes mellitus.
6. Cases of meconium or amniotic fluid aspiration.
7. Patients with obstetric complications like antepartum hemorrhages and congenital malformations
8. Patients for whom regional anesthesia was contraindicated

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed using sequentially numbered, opaque, sealed envelopes prepared by an independent statistician. The envelopes were opened sequentially after participant enrolment by a staff member not involved in outcome assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence was generated using computer-based block randomization with variable block sizes by an independent statistician not involved in participant recruitment or assessment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS (Version 26.0) will be used for the statistical analysis.
Descriptive Analysis:
• For Quantitative Variables:
• Variables: Anxiety levels (measured by APAIS), Apgar scores (1-minute and 5- minute).
• Mean and standard deviation (SD) will be calculated for:
• APAIS anxiety scores (both before and after midazolam administration).
• Apgar scores at 1 and 5 minutes for both groups.
• For Qualitative Variables:
• Variables: Patient demographics (age, ASA class), and the presence of side effects (nausea, vomiting, dizziness, etc.).
• Frequency and percentages will be calculated for:
• Age groups, ASA class distribution, incidence of complications in both groups.
• Test: Independent Samples t-test will be used to compare the mean anxiety scores between the two groups (Group I vs. Group II).
• t-test will also be used to compare Apgar scores (at 1 minute and 5 minutes) between the two groups.
• Test: Chi-square test will be used to evaluate the association between midazolam use and the occurrence of complications (nausea, vomiting, headache, dizziness, etc.).
• P<0.05 will be taken as level of significance

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2026
Date of last participant enrolment
Anticipated
30/11/2026
Actual
Date of last data collection
Anticipated
5/12/2026
Actual
Sample size
Target
80
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 27854 0
Pakistan
State/province [1] 27854 0
Punjab

Funding & Sponsors
Funding source category [1] 321231 0
Hospital
Name [1] 321231 0
Holy Family Hospital Rawalpindi
Country [1] 321231 0
Pakistan
Primary sponsor type
University
Name
Rawalpindi Medical University (RMU)
Address
Country
Pakistan
Secondary sponsor category [1] 323937 0
None
Name [1] 323937 0
Address [1] 323937 0
Country [1] 323937 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319757 0
Research and Ethical Committee Rawalpindi medical university and Allied Hospitals
Ethics committee address [1] 319757 0
Ethics committee country [1] 319757 0
Pakistan
Date submitted for ethics approval [1] 319757 0
05/01/2026
Approval date [1] 319757 0
04/02/2026
Ethics approval number [1] 319757 0
136/IREF/RMU/2026

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 148302 0
Dr Asifa Saeed
Address 148302 0
Rawalpindi medical university,Tipu road,Chamanzar colony, Rawalpindi, Punjab, Pakistan,postal code 46000
Country 148302 0
Pakistan
Phone 148302 0
+923224695900
Fax 148302 0
Email 148302 0
[email protected]
Contact person for public queries
Name 148303 0
Asifa Saeed
Address 148303 0
Rawalpindi medical university,Tipu road,Chamanzar colony, Rawalpindi, Punjab, Pakistan,postal code 46000
Country 148303 0
Pakistan
Phone 148303 0
+923224695900
Fax 148303 0
Email 148303 0
[email protected]
Contact person for scientific queries
Name 148304 0
Asifa Saeed
Address 148304 0
Rawalpindi medical university,Tipu road,Chamanzar colony, Rawalpindi, Punjab, Pakistan,postal code 46000
Country 148304 0
Pakistan
Phone 148304 0
+923224695900
Fax 148304 0
Email 148304 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Confidential will be maintain



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approvalERB Letter [email protected] ERB Letter.pdf
Informed consent formRecruitment Material [email protected] Consent Form English.pdf
Study protocolResearch Protocol [email protected] Interventional-research-protocol.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.