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临床试验/CTRI/2024/07/071635
CTRI/2024/07/071635尚未招募不适用

Impact of pregnancy related lumbopelvic pain on labor and delivery outcomes:Analytic cohort study .

Pgims Rohtak1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
c section

研究概览

简要总结

Title :Impact of pregnancy  Related lumbopelvic pain on labor and delivery Outcomes.

Low back pain (LBP) has been defined as any discomfort or pain between the 12th rib and  the gluteal fold .

Another term lumbopelvic (LPP) pain is defined as recurrent or constant pain

for more than 1 week in lumbopelvic region during pregnancy.

Pelvic girdle pain (PGP) is another type of pain which is described by some authors, as pain localized in the sacroiliac joint’s area, with or without involvement of posterior thigh and pubic symphysis. In the past literature though the classification remained uncertain, in a recent consensus paper it is stated that PGP should be considered as a specific form of LBP that can occur alone or in combination to LBP.LBP is a very common problem which leads to significant social and economic costs worldwide,As per current literature, prevalence in Pregnant women varies, most studies report a prevalence of about 50 to 86 percent.

Former LBP episodes and previous pregnancies LBP are not linked to period of gestation, any previous back or pelvis trauma, strenuous working activity, and  fetomaternal weight ,Evidences show that physical exercise during pregnancy and delivery outcomes are strictly related to each other 6-13. Besides all the expected advantages of physical activity on maternal and fetal metabolic balance, it is known that labor’s coping strategies, childbirth dynamics, and mode of delivery can b interfered by presence of LBP during pregnancy.

PGP and PLBP usually starts around 8th week of pregnancy and peak intensity between 24th -36th week, but it can also start in the first trimester or be delayed as late as three weeks after delivery.Women with PGP and PLBP find difficulty with normal activities such as getting up from sitting position, turning over bed, prolonged sitting, pro nalyse the labor and delvery outcomes in women with pregnancy rated

lumbopelvic pain (PRLPP) and compare with women without PRLPP.

OBJECTIVE

Primary Objectives

ï‚· To study and compare the mode of delivery in women with PRLPP and without

PRLPP.

ï‚· To monitor the progress of labor in women delivering vaginally .

ï‚· To record maternal and neonatal complications in perinatal peroid .

Secondary objective

ï‚· To assess the impact of lumbopelvic pain in immediate postpartum.

INCLUSION CRITERIA

Antenatal women with singleton pregnancy with a history of PRLPP in the current pregnancy

would be enrolled for the study at gestational age >=34weeks and before onset of labor.

Study population:

Study cohort: Antenatal women with history of PRLPP in current pregnancy.

Comparison cohort :Antenatal women without PRLPP

Sample size :200

100 will be with pain

100 without pain

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • With recurrent or persistent pregnancy-related lumbopelvic pain.

排除标准

  • Ortho condition Infection Trauma Tumor.

结局指标

主要结局

c section

时间窗: 4-6weeks

Normal birth

时间窗: 4-6weeks

Duration of labor

时间窗: 4-6weeks

次要结局

  • Pain 24hrs after delivery(Impact on breastfeeding)

研究者

发起方
Pgims Rohtak
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Nasreen Chowdhary

Government medical college

研究点 (1)

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