A CLINICAL TRIAL TO STUDY THE COMPARISON BETWEEN ULTRASOUND PARAMETERS AND DIGITAL VAGINAL EXAMINATION TO ASSESS FETAL HEAD STATION IN LABOR

Not yet recruiting

• Conditions: Encounter for full-term uncomplicated delivery,

• Registration Number: CTRI/2021/02/030936
• Lead Sponsor: KASTURBA HOSPITAL

Brief Summary

Prospective observational study will be conducted in Kasturba Hospital, Manipal. Ethical clearance by Institutional ethical committee (IEC), Kasturba hospital is taken. Pregnant women admitted in the hospital will be screened for inclusion and exclusion criteria through proforma where baseline demographic characteristics will be obtained. A written informed consent from the participants will be taken after a brief explanation about the procedure.

Ultrasound probe is enclosed in a powder free latex glove will be placed in the maternal perineum in midsaggital plane between the labia. Head perineum distance will be measured by holding transducer transversely over the ischial tuberosity. Ultrasound parameters will be measured and recorded in a data sheet. Ultrasound parameters are-

i. Intrapartum trans perineal ultrasound fatal head station

ii. Head perineum distance

iii. Angle of descent

Vaginal examination will be done by the managing clinician and will be blinded to the ultrasound data and will coincide with TPU assessments.

All the above mentioned findings will be recorded in a data sheet to evaluate the correlation coefficient( r).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-01-25
• Study Start: 2021-05-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

• Pregnant women who are scheduled for induction of labor or with spontaneous onset of labor 2.
• Singleton pregnancy at gestational age 36 to 40 weeks 3.
• Women in labor and regular uterine contractions and changes in cervical dilatation of more than 2 cm.

Exclusion Criteria

• Previous LSCS 2.
• Multiple pregnancy 3.
• Cephalopelvic Disproportion 4.
• Abnormal cardiotocography at enrollment.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. Correlation between the ultrasound parameters and digitally palpated fetal head station	22 months
1. Correlation between the ultrasound parameters	22 months

Secondary Outcome Measures

Name	Time	Method
Outcome of labor	22 months

Trial Locations

Locations (1)

Kasturba Hospital; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hospital

🇮🇳Udupi, KARNATAKA, India

Dr Jyothi Shetty

Principal investigator

9845973697

jyothi.shetty@manipal.edu