NCT05070468

Effect of Dexamethasone on Labor Induction

The Effect of Using Dexamethasone Tablets Vaginally On Improving Cervical Bishop Score in Nulliparous Pregnant Women. A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Alborz Medical University · Other Government
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: The sample size required to compare the mean of the two groups, with a 95% confidence interval and 90% test power, and considering the technical difference of 0.5 hours, was estimated to be 84 people. Then patients, randomly assigned using the block method with statistician help, were divided into two groups of 42 cases and control. The present study was performed on 82 full-term pregnant females (38 weeks or more).they had an indication 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. Group A received 14 dexamethasone tablets with a dose of 0.5 mg for vaginal use and also group B received 14 placebo tablets for vaginal use. Patients who were Iranian, Prim gravid pregnancy with Normal Body Mass Index (BMI), Single Pregnancy presentation cephalic in Sonography, Aged 18 years old to 35 years old, Gestational age 38 weeks, Bishop score 2 and less, with Normal Non-Stress Test (NST), Estimate of Fetus Weight 2500-4000 gr and didn't take hormonal, herbal and chemical drugs and having a healthy water bag were enrolled to this Study. Patients who had Medicine and Midwifery Complications, Lack of Desire for Cooperation, Fetal Immobility, and Maternal Bleeding were excluded.

Conditions

• Dexamethasone
• Pregnancy

Interventions

Type	Name	Description
DRUG	Dexamethasone 0.5mg	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.
DRUG	Placebo	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.

Timeline

• Start date: 2020-11-22
• Primary completion: 2021-01-21
• Completion: 2021-03-21
• First posted: 2021-10-07
• Last updated: 2024-12-12
• Results posted: 2024-12-12

Locations

1 site across 1 country: Iran