Clinical trial NCT05070468: Effect of Dexamethasone on Labor Induction
Official title: The Effect of Using Dexamethasone Tablets Vaginally On Improving Cervical Bishop Score in Nulliparous Pregnant Women. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dexamethasone
Pregnancy
Lead sponsor: Alborz Medical University
Sponsor class: OTHER_GOV
First posted: 2021-10-07
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: First Bishop Score
timeFrame: at the beginning of the study
measure: Second Bishop Score
timeFrame: 6 hours after vaginally tablets installment
measure: The Latent Phase of Labor
timeFrame: from the beginning of the study to the time of 6 cm dilation of cervix
Secondary outcomes:
Other outcomes:
Locations:
city: Karaj
country: Iran, Islamic Republic of
facility: Alborz university of medical sciences
Study officials:
affiliation: Assistant Professor of Alborz University of Medical Sciences
name: Masoumeh Farahani, Doctor
role: STUDY_DIRECTOR
References: