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A research to find out fetal wellbeing in labour by using a sound stimulus over abdomen of the pregnant mother and recording fetal heart rate (FHR) changes on a piece of paper, in a low resource settings where sophisticated costly techniques are not widely available.

Role of Fetal Vibroacoustic Stimulation Test as an Adjunct to Non-reassuring Cardiotocography in Labour.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/001418
Enrollment
60
Registered
2010-11-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Vibroacoustic stimulation or VAS group: A total of 60 women have been randomized into either study group (Vibroacoustic stimulation or VAS group) or control group (non-VAS group) accord

Sponsors

Dr Sanjib Dutta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women with gestational age ≥ 30 weeks with no known congenital anomalies, admitted in labour ward with features of non-reassuring cardiotocography. In this study for application of VAS, the CTG trace is defined as non-reassuring if it fulfills one of the following criteria in 20 minutes record: 1. No acceleration, 2. Variability <5 beats per minute (bpm), 3. Baseline 100-109. (RCOG criteria 2001, FIGO 1987)

Exclusion criteria

Exclusion criteria: Women who require immediate delivery such as abruptio placentae, suspected scar dehiscence or cord prolapse, 2. In cases where there is evidence of normal or pathological cardiotocography, 3. Multifetal pregnancies, 4. Presence of any fetal malformation, 5. Exposure to narcotic drugs within 4 hours.

Design outcomes

Primary

MeasureTime frame
Primary outcome measures included: changes in baseline, variability>5, number of acceleration or deceleration and method of delivery (rate of normal delivery, operative vaginal delivery and caesarean sections) among two groups. Caesarean sections and operative vaginal delivery due to fetal distress were analyzed.Timepoint: Till discharge/upto 28 days of delivery.—

Secondary

MeasureTime frame
Perinatal outcome which included Apgar score <3 and <7 at both 1 minute and 5 minute, requirement for neonatal resuscitation, need for transfer to NICU, evidence of HIE, multi-organ dysfunction and perinatal mortality were compared between two groups. Need for consumable CTG papers between two groups and its average cost were also studied between two groups.Timepoint: Till discharge/upto 28 days of delivery.—

Countries

India

Contacts

Public ContactDr Sanjib Dutta
dr_sanjib_2007@yahoo.co.in03222274321

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026