The Effect of Using Dexamethasone Tablets Vaginally On Improving Cervical Bishop Score in Nulliparous Pregnant Women. A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- First Bishop Score
研究概览
简要总结
Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the a statistician did coding to identify groups of users of pill A or pill B, 14 pills are used vaginally. The patients and the researcher is blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
详细描述
Study design:
This study was a clinical trial with the control group, blinded, randomized with a block method that was done at Kamali Hospital, Karaj, Iran.
This study was carried out between October 2019 and June 2021. At first, the researchers registered this study on the RCT(randomized controlled trial) site with the following number: IR.ABZUMS.REC1399.067.
A written consent form was obtained from all patients and the ethics committee of Alborz University of Medical Sciences confirmed the study protocol.
Study selection:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Iranian Women
- •Primigravid pregnancy
- •Normal of Body Mass Index
- •Single Pregnancy
- •presentation cephalic in sonography
- •Gestational age 38 weeks
- •Bishop score 2 and less
- •Normal Non Stress
- •Test Estimate of Fetus Weight 2500-4000 gr
- •Didn't take hormonal, herbal and chemical drugs
- •having a healthy water bag
排除标准
- •Have Medicine And Midwifery Complication
- •Lack of Desire for Cooperation
- •Fetal Immobility
- •Maternal Bleeding
研究组 & 干预措施
Group A
Prescribing Vaginally Dexamethasone tablets to the Group A
干预措施: Dexamethasone 0.5mg (Drug)
Group B
Prescribing Vaginally placebo tablets to the Group B
干预措施: Placebo (Drug)
结局指标
主要结局
First Bishop Score
时间窗: at the beginning of the study
The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5\>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%\>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome).
Second Bishop Score
时间窗: 6 hours after vaginally tablets installment
The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5\>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%\>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome).
The Latent Phase of Labor
时间窗: from the beginning of the study to the time of 6 cm dilation of cervix
measured by Vaginal Examination
次要结局
未报告次要终点
研究者
Matineh Nirouei
Principal Investigator
Alborz Medical University