Effect of Dexamethasone on Labor Induction
Condition: Dexamethasone; Pregnancy
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Dexamethasone 0.5mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Pill A; Pill B
Intervention MeSH terms: Dexamethasone
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment