Effect of Dexamethasone on Labor Induction

Alborz Medical University

Status and phase: Completed; Phase 3

Conditions: Pregnancy; Dexamethasone

Treatments: Drug: Placebo; Drug: Dexamethasone 0.5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05070468

IR.ABZUMS.REC.1399.067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

Prescribing Vaginally Dexamethasone tablets to the Group A

Treatment:

Drug: Dexamethasone 0.5mg

Group B

Placebo Comparator group

Description:

Prescribing Vaginally placebo tablets to the Group B

Treatment:

Drug: Placebo