Effect of Dexamethasone on Labor Induction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dexamethasone, Pregnancy

Intervention / Treatment
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* Drug: Dexamethasone 0.5mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects are assigned to two groups by randomization block balanced method allocation and using quadruple blocks. In this case, there are 6 modes And in each case, 2 people will be in the control group and 2 people will be in the intervention group. Thus, by using the table of random numbers and assigning the numbers 1 to 6 to groups of 4 people, people are finally assigned to two groups of intervention and control.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Prescribing Vaginally Dexamethasone tablets to the Group A | Drug: Dexamethasone 0.5mg<br>* 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.<br>* Other names: Pill A;|
| Placebo Comparator: Group B<br>Prescribing Vaginally placebo tablets to the Group B | Drug: Placebo<br>* 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.<br>* Other names: Pill B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |