跳至主要内容
临床试验/CTRI/2024/03/064849
CTRI/2024/03/064849招募中不适用

Labor Related Indications as determinant for primary cesarean deliveries in various Robson groups.

VMMC AND Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年4月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Number of women with labor related indications undergoing primary cesarean delivery in Robson groups.

研究概览

简要总结

AIM:

To evaluate labour related indications as determinant of primary caesarean delivery in various

Robson groups.

OBJECTIVE:

To evaluate labour related indications as determinant of primary caesarean delivery in various Robson

groups.

VENUE OF STUDY: Department of Obstetrics & Gynaecology, VMMC & Safdarjung Hospital,

New Delhi.

TYPE OF STUDY: Prospective observational Study

DURATION OF STUDY: 18 months

The study will be conducted in Department of Obstetrics & Gynaecology, VMMC & Safdarjung

Hospital, New Delhi.

METHODOLOGY: This prospective observational study will be done on 300 antenatal women without

prior cesarean delivery. Antenatal women admitted for delivery in the department of OBGYN, SJH will be

assigned a Robson group based on Robson ten group classification system which is further based on five

obstetric parameters viz parity, onset of labor, gestational age, presentation and number of fetuses. This

classification is as follows

Group Description

1 Nullipara, single, cephalic, term pregnancy, spontaneous labour

2 Nullipara, single, cephalic, term, induced labour or planned CS

3 Multipara without uterine scar, single, cephalic, term, spontaneous

labour

4 Multipara without uterine scar, single, cephalic, term, induced

labour or planned CS

5 Multipara with uterine scar, single, cephalic, term

6 Nullipara, single, Breech presentation

7 Multipara, single, breech, including previous C-Section

8 Multiple Pregnancy

9 Single, abnormal lie, including previous scar

10 Single, Cephalic, Preterm including previous scar

These women will be followed by monitoring progress of labor and fetal heart rate as per

departmental protocol. The women in various Robson groups undergoing primary cesarean

delivery will be followed. The number of women undergoing primary cesarean delivery for both

labor and non-labor related indications will be noted. The labor related indications will comprise

of protracted labor, arrest of labor, second stage arrest.

Basic clinic-demographic parameters like age, obstetric history, gravidity, parity, details of labor

will be recorded on a preformed proforma. These women will be followed for feto-maternal

outcomes as follows.

The maternal parameters that will be noted are stage of labor, period of gestation, presence of

comorbidity, immediate cause of caesarean section, intra-operative complication like PPH/Trauma,

need for blood transfusion, need of HDU/ICU stay, need of life support system ultimate final outcome

(discharged / death).

The fetal parameters that will be noted are birth weight, APGAR Score at 5 min, NICU stay, ultimate

neonatal outcome (discharged / death).

The number of women in various Robson groups who will be delivered vaginally will also be noted.

The data will be entered into excel sheet and will be subjected to statistical analysis

Outcome

Number of women with labor related indications undergoing primary cesarean delivery in Robson groups.

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

  • All antenatal women in third trimester.

排除标准

  • 未提供

结局指标

主要结局

Number of women with labor related indications undergoing primary cesarean delivery in Robson groups.

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
VMMC AND Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Divya Pandey

Safdarjung hospital,Delhi

研究点 (1)

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