Effect of Dexamethasone on Labor Induction

Phase 3

Completed

Conditions: Dexamethasone
Pregnancy

Interventions: Drug: Dexamethasone 0.5mg
Drug: Placebo

Registration Number: NCT05070468

Lead Sponsor: Alborz Medical University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 84

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Dexamethasone 0.5mg	Prescribing Vaginally Dexamethasone tablets to the Group A
Group B	Placebo	Prescribing Vaginally placebo tablets to the Group B

Primary Outcome Measures

Name	Time	Method
First Bishop Score	at the beginning of the study	The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5\>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%\>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome).
Second Bishop Score	6 hours after vaginally tablets installment	The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5\>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%\>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome).
The Latent Phase of Labor	from the beginning of the study to the time of 6 cm dilation of cervix	measured by Vaginal Examination