Effect of Dexamethasone on Labor Induction

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05070468
• Other study ID #: IR.ABZUMS.REC.1399.067
• Status: Completed
• Phase: Phase 3
• Start date: November 22, 2020
• Est. completion date: March 21, 2021

Study information

• Verified date: October 2021
• Source: Alborz Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

Study design:

This study was a clinical trial with control group, blinded, randomized with 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 site with the following number: IR.ABZUMS.REC1399.067.

A written consent form was obtained from all patients and ethics committee of Alborz University of Medical Sciences confirmed the study protocol.

Study selection:

The sample size that require 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 block method with statistician help, was divided into two groups of 42 case and control.

The present study was performed on 82 full term pregnant females (38 weeks or more).they had 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 of Body Mass Index (BMI), Single Pregnancy presentation cephalic in Sonography, Age 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 Complication, Lack of Desire for Cooperation, Fetal Immobility and Maternal Bleeding were excluded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Have Medicine And Midwifery Complication

• Lack of Desire for Cooperation

• Fetal Immobility

• Maternal Bleeding

Related Conditions & MeSH terms

• Dexamethasone
• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alborz university of medical sciences	Karaj

Sponsors (1)

Lead Sponsor	Collaborator
Alborz Medical University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change the cervical ripening	Evaluation of cervical bishop score From the time of entering the labor and 6 hours after vaginal use of dexamethasone tablets	6 hours
Primary	change the duration of the latent phase of labor	From the time of entering the labor to a bishop score of 4 and above	10 hours