跳至主要内容
临床试验/CTRI/2024/04/065413
CTRI/2024/04/065413已完成不适用

Effectiveness of nipple stimulation technique in aiding spontaneous onset of labor in low risk primigravida

NA1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2024年4月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
142
试验地点
1
主要终点
To be observed in both groups in the form of maternal, fetal outcomes. Maternal outcomes such as change in the Bishop’s score after 2 weeks, spontaneous or induced labour, Induction for post-datism, mode of delivery, duration of labour and any hyperstimulation, meconium-stained liquor

研究概览

简要总结

Low risk Primigravida who are at 37completed weeks of gestation, fitting the inclusion criteria will be recruited from the OPD during their routine antenatal visit to the hospital. A baseline cervical scoring using Bishop’s score will be done along with pelvic assessment and those with cephalopelvic disproportion will be excluded. These low risk pregnant women will be provided charts explaining the technique of nipple stimulation and its advantages as per

the consultant’s advice. The women who are consenting for the study will be taken as stimulation group and those are not willing for the study will be taken as non- stimulation group (each with sample size of 71). This nipple stimulation is a standard method of practice in some units, as it helps in cervical ripening and timely onset of labour without use of any pharmacological means. These women will be followed weekly in their regular weekly

antenatal follow up. No extra visits will be required for this study. They will be advised to keep a daily dairy of the manoeuvre and to be shown in the subsequent visit. At 39weeks, these women are to be followed up and those who has not done the manoeuvre will be excluded from the study. A repeat Bishop’s score has to be done at 39+ weeks of gestation, and changes in the cervical scoring to be noted in both the groups. These women will be

advised to attend immediately to the obstetric casualty in case of pain abdomen associated with tightening, leaking or bleeding PV or decreased fetal movements.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Low risk primigravida who completed 37weeks of gestation with cephalic presentation, and no other medical (such as diabetes, hypertension, hypothyroidism etc,) and surgical complications.

排除标准

  • Those who have medical and surgical complications and other pregnancy related complications such as cephalo-pelvic disproportion, h/o assisted reproductive techniques and those who are not willing for the study.

结局指标

主要结局

To be observed in both groups in the form of maternal, fetal outcomes. Maternal outcomes such as change in the Bishop’s score after 2 weeks, spontaneous or induced labour, Induction for post-datism, mode of delivery, duration of labour and any hyperstimulation, meconium-stained liquor

时间窗: at the time of recruitment

Fetal outcomes such as Apgar score at 5 mins, requirement of neonatal intensive care unit admission, neonatal morbidities like sepsis, asphyxia, jaundice, respiratory distress, fetal or neonatal death.

时间窗: at the time of recruitment

次要结局

  • -(-)

研究者

发起方
NA
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

Dr. GEETHANJALI ADDALA

KMC, Manipal

研究点 (1)

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