跳至主要内容
临床试验/CTRI/2024/03/064115
CTRI/2024/03/064115尚未招募不适用

To assess the Role of Transvaginal Sonographic cervical score and Bishop’s score in prediction of successful labor induction at a Tertiary Care Centre

MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
TO ASSESS THE BISHOP SCORE PARAMETER AND COMPARE THEM WITH SONOGRAPHIC PARAMETERS.

研究概览

简要总结

Induction of labor is an artificial method of initiating uterine contractions before the onset of spontaneous labour, leading to progressive cervical dilatation and effacement followed by delivery. Until now Modified Bishops score was the most commonly used method for evaluation of preindicting favourability of cervix but now TVS is becoming more reliable because the supravaginal portion of the cervix is hard to assess digitally. Hence to avoid subjective variations, role of TVS parameters are taken into consideration in Predicting outcomes of Labor Induction.  Most common indications include post-term pregnancy (27%), Rupture of membranes prior to labour (26%) 3. Appropriate selection of cases is crucial prior to induction, out of those, cervical status is one of the most important factors in predicting the likelyhood of successful induction of labour.

The Bishop scoring system is based on a digital cervical exam of a patient with a zero point minimum and 13 point maximum.  The scoring system utilizes cervical dilation, position, effacement, consistency of the cervix, and fetal station. Cervical dilation, effacement, and station are scored 0 to 3 points, while cervical position and consistency are scored 0 to 2 points 4. A Bishop score of 8 or greater is considered to be favourable for induction, or the chance of a vaginal delivery with induction is similar to spontaneous labor.  A score of 6 or less is considered to be unfavourable if an induction is indicated cervical ripening agents may be utilized.

Transvaginal sonography (TVS) as an objective method of assessment of cervix.  TVS cervical score comprises of five different parameters; cervical length, funneling at the internal os, distance from the presenting part to the external os, and cervix position 5.

These parameters were selected to match the components of Bishop’s Score—cervical length was comparable to effacement of cervix; cervical station was represented as distance of the presenting part to the external os and cervical dilatation was assessed by measurement of width and length of the funnel. The cervical funneling is an important predictor of successful induction as its presence may associated with reduction of delivery time [5]

Based on the description above, this study will aim to compare the success of labor induction with Cervical assessment using a Transvaginal ultrasonography and Bishop score assessment.

A randomised clinical compare study on patients aged 22–40 years, ANC patients in the time period between April 2023- October 2024 will be conducted. Data will be collected by using self design questionnaire. Entire data would be entered into a microsoft office software and appropriate statistical test will be applied and results will be calculated.

研究设计

研究类型
Observational

入排标准

年龄范围
22.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Patients with history of uterine surgeries like previous LSCS, myomectomy.
  • Placental Abnormalities like placenta previa and suspected placenta accreta etc.
  • Systemic diseases like liver dysfunction, kidney dysfunction and heart disease.
  • Women with major fetal anomalies Patients having Fetal distress before onset of active labor after Induction.
  • Patients with ruptured Membranes Patients who have any contraindication for vaginal delivery Patients who refuse to give consent.

排除标准

  • Patients with history of uterine surgeries like previous LSCS, myomectomy.
  • Placental Abnormalities like placenta previa and suspected placenta accreta etc.
  • Systemic diseases like liver dysfunction, kidney dysfunction and heart disease.
  • Women with major fetal anomalies Patients having Fetal distress before onset of active labor after Induction.
  • Patients with ruptured Membranes Patients who have any contraindication for vaginal delivery Patients who refuse to give consent.

结局指标

主要结局

TO ASSESS THE BISHOP SCORE PARAMETER AND COMPARE THEM WITH SONOGRAPHIC PARAMETERS.

时间窗: To identify an objective method for prediction of successful induction of labour

次要结局

  • Transvaginal Sonographic cervical score & Bishop’s score in prediction of successful labor induction(To identify an objective method for prediction of successful induction of labour)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Divya Shah

MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL

研究点 (1)

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