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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Dexamethasone
• Intervention / Treatment: Drug: Dexamethasone 0.5mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Karaj, Iran, Islamic Republic of, 3149779453
    • Alborz university of medical sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Prescribing Vaginally Dexamethasone tablets to the Group A	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.; Other Names: Pill A
Placebo Comparator: Group B; Prescribing Vaginally placebo tablets to the Group B	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.; Other Names: Pill B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Bishop Score	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).	at the beginning of the study
Second Bishop Score	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).	6 hours after vaginally tablets installment
The Latent Phase of Labor	measured by Vaginal Examination	from the beginning of the study to the time of 6 cm dilation of cervix

Collaborators and Investigators

• Sponsor: Alborz Medical University
• Investigators: Study Director: Masoumeh Farahani, Doctor, Assistant Professor of Alborz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2020
• Primary Completion (Actual): January 21, 2021
• Study Completion (Actual): March 21, 2021

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: October 26, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: IR.ABZUMS.REC.1399.067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No