Effect of Dexamethasone on Labor Induction

NCT05070468 | Completed Phase 3 Results

• 1 other identifier: IR.ABZUMS.REC.1399.067
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexamethasone; Pregnancy

Outcome Measures

Primary Outcomes (3)

• First Bishop Score

  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).

  at the beginning of the study

• Second Bishop Score

  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).

  6 hours after vaginally tablets installment

• The Latent Phase of Labor

  measured by Vaginal Examination

  from the beginning of the study to the time of 6 cm dilation of cervix

Study Arms (2)

Group A

ACTIVE COMPARATOR

Prescribing Vaginally Dexamethasone tablets to the Group A

Drug: Dexamethasone 0.5mg

Group B

PLACEBO COMPARATOR

Prescribing Vaginally placebo tablets to the Group B

Drug: Placebo

Interventions

Dexamethasone 0.5mg DRUG

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.

Also known as: Pill A

Group A

Placebo DRUG

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.

Also known as: Pill B

Group B

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Have Medicine And Midwifery Complication
• Lack of Desire for Cooperation
• Fetal Immobility
• Maternal Bleeding

Sponsors & Collaborators

• Alborz Medical University: lead

Study Sites (1)

Alborz university of medical sciences

Karaj, 3149779453, Iran

Location

Related Publications (1)

• Farahani M, Nirouei M, Moghadam S, Hashemnejad M, Mashak B, Alinia T, Torabi S. The Effect of Using Dexamethasone Tablets Vaginally for Improving Cervical Bishop Score in Nulliparous Pregnant Women: A Randomized Clinical Trial. Curr Ther Res Clin Exp. 2023 Apr 6;98:100702. doi: 10.1016/j.curtheres.2023.100702. eCollection 2023.

  PMID: 37101983 DERIVED

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Masoumeh Farahani
• Organization: Alborz University of Medical Sciences

drfarahani73@yahoo.com

09123783823

Study Officials

• Masoumeh Farahani, Doctor

  Assistant Professor of Alborz University of Medical Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 7, 2021
• Study Start: November 22, 2020
• Primary Completion: January 21, 2021
• Study Completion: March 21, 2021
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)