Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05070468 |
| Other study ID # |
IR.ABZUMS.REC.1399.067 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
November 22, 2020 |
| Est. completion date |
March 21, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Alborz Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
