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临床试验/CTRI/2023/12/060836
CTRI/2023/12/060836已完成不适用

Association of plasma leptin levels with outcome of induction of labour in pregnant women

Dr Priya Lal1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年1月1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
180
试验地点
1
主要终点
1. Maternal plasma Leptin levels

研究概览

简要总结

Maternal obesity is associated with a significant increase in the incidence of miscarriage, congenital anomalies, macrosomia, gestational diabetes, gestational hypertension, preeclampsia and stillbirth. Leptin is an important biomarker responsible for the regulation of energy homeostasis. It has regulatory effects on neuronal tissue, vascular smooth muscle, and nonvascular smooth muscle systems . Placenta is also a major source of leptin production during pregnancy.

Leptin has been identified as an independent predictor of dysfunctional labor and is associated with increased risk of failed induction of labor resulting in cesarean section.It may play an important role in dysfunctional labor and be associated with the outcome of induction of labor at term. Our aim is to determine whether maternal plasma leptin concentration is indicative of the outcome of induction of labor at term. We hypothesize that elevated maternal plasma leptin levels are associated with a failed term induction of labor resulting in a cesarean delivery.

Ref - Cowman, W., Scroggins, S.M., Hamilton, W.S. Association between plasma leptin and cesarean section after induction of labor: a case control study. BMC Pregnancy Childbirth, Article no. 29. 2022

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 49.00 Year(s)(—)
性别
Female

入选标准

  • All antenatal women at more than or equal to 37 weeks of gestation who have undergone induction of labour by any method (misoprostol, dinoprostone, PGE2 gel, oxytocin, artificial rupture of membranes, membrane stripping or Foley’s balloon placement).

排除标准

  • Multiple gestation Fetal anomalies Augmentation of labour rather than induction of labour Intrauterine fetal death.

结局指标

主要结局

1. Maternal plasma Leptin levels

时间窗: From 37 weeks POG till 2 weeks postnatally

2.Success or failure of Induction of labour

时间窗: From 37 weeks POG till 2 weeks postnatally

3.Mode of delivery

时间窗: From 37 weeks POG till 2 weeks postnatally

4.Fetal birth weight

时间窗: From 37 weeks POG till 2 weeks postnatally

5.Fetal APGAR

时间窗: From 37 weeks POG till 2 weeks postnatally

6.Admission to NICU

时间窗: From 37 weeks POG till 2 weeks postnatally

7.Administration of neonatal antibiotics

时间窗: From 37 weeks POG till 2 weeks postnatally

次要结局

  • 1. Fetal birth weight(2.Fetal APGAR)

研究者

发起方
Dr Priya Lal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR PRIYA LAL

VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL

研究点 (1)

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