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Effect of Dexamethasone on Labor Induction

Sponsor
Alborz Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05070468
Collaborator
(none)
84
Enrollment
1
Location
2
Arms
3.9
Actual Duration (Months)
21.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone 0.5mg
  • Drug: Placebo
 Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
The Effect of Using Dexamethasone Tablets Vaginally On Improving Cervical Bishop Score in Nulliparouse Pregnant Women. A Randomized Clinical Trial
Actual Study Start Date :
Nov 22, 2020
Actual Primary Completion Date :
Jan 21, 2021
Actual Study Completion Date :
Mar 21, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change the cervical ripening [6 hours]

      Evaluation of cervical bishop score From the time of entering the labor and 6 hours after vaginal use of dexamethasone tablets

    2. change the duration of the latent phase of labor [10 hours]

      From the time of entering the labor to a bishop score of 4 and above

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alborz university of medical sciences Karaj Iran, Islamic Republic of 3149779453

    Sponsors and Collaborators

    • Alborz Medical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matineh Nirouei, Principal Investigator, Alborz Medical University
    ClinicalTrials.gov Identifier:
    NCT05070468
    Other Study ID Numbers:
    • IR.ABZUMS.REC.1399.067
    First Posted:
    Oct 7, 2021
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dexamethasone

    Study Results

    No Results Posted as of Oct 7, 2021