Trial Outcomes & Findings for Effect of Dexamethasone on Labor Induction (NCT NCT05070468)

Last Updated: 2024-12-12

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

84 participants

Primary outcome timeframe

at the beginning of the study

Results posted on

2024-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Dexamethasone Prescribing Vaginally Dexamethasone tablets to the Group A Dexamethasone 0.5mg: 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.	Placebo Prescribing Vaginally placebo tablets to the Group B Placebo: 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.
Overall Study STARTED	42	42
Overall Study COMPLETED	41	42
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=42 Participants Prescribing Vaginally Dexamethasone tablets to the Group A Dexamethasone 0.5mg: 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.	Group B n=42 Participants Prescribing Vaginally placebo tablets to the Group B Placebo: 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.	Total n=84 Participants Total of all reporting groups
Age, Continuous	25 years n=42 Participants	23 years n=42 Participants	24 years n=84 Participants
Sex: Female, Male Female	42 Participants n=42 Participants	42 Participants n=42 Participants	84 Participants n=84 Participants
Sex: Female, Male Male	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Education Illiterate	4 Participants n=42 Participants	6 Participants n=42 Participants	10 Participants n=84 Participants
Education Primary school	2 Participants n=42 Participants	5 Participants n=42 Participants	7 Participants n=84 Participants
Education Junior school	14 Participants n=42 Participants	7 Participants n=42 Participants	21 Participants n=84 Participants
Education High school	16 Participants n=42 Participants	19 Participants n=42 Participants	35 Participants n=84 Participants
Education Associate's degree	2 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=84 Participants
Education Bachelor's degree or higher	4 Participants n=42 Participants	3 Participants n=42 Participants	7 Participants n=84 Participants
Job Unemployed	37 Participants n=42 Participants	40 Participants n=42 Participants	77 Participants n=84 Participants
Job employed	5 Participants n=42 Participants	2 Participants n=42 Participants	7 Participants n=84 Participants
Gravidity and parity G1ab1	42 Participants n=42 Participants	40 Participants n=42 Participants	82 Participants n=84 Participants
Gravidity and parity G1ab2	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=84 Participants
Gravidity and parity G1ab3	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=84 Participants

PRIMARY outcome

Timeframe: at the beginning of the study

Outcome measures

Outcome measures
Measure	Dexamethasone n=41 Participants Prescribing Vaginally Dexamethasone tablets to the Group A Dexamethasone 0.5mg: 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.	Placebo n=42 Participants Prescribing Vaginally placebo tablets to the Group B Placebo: 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.
First Bishop Score	1 score on a scale Interval 1.0 to 2.0	1 score on a scale Interval 1.0 to 2.0

PRIMARY outcome

Timeframe: 6 hours after vaginally tablets installment

Outcome measures

Outcome measures
Measure	Dexamethasone n=41 Participants Prescribing Vaginally Dexamethasone tablets to the Group A Dexamethasone 0.5mg: 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.	Placebo n=42 Participants Prescribing Vaginally placebo tablets to the Group B Placebo: 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.
Second Bishop Score	3.5 score on a scale Interval 2.0 to 4.0	3 score on a scale Interval 2.0 to 4.0

PRIMARY outcome

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

measured by Vaginal Examination

Outcome measures

Outcome measures
Measure	Dexamethasone n=41 Participants Prescribing Vaginally Dexamethasone tablets to the Group A Dexamethasone 0.5mg: 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.	Placebo n=42 Participants Prescribing Vaginally placebo tablets to the Group B Placebo: 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.
The Latent Phase of Labor	4 hour Interval 0.0 to 9.0	5 hour Interval 0.0 to 8.0

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Masoumeh Farahani

Alborz University of Medical Sciences

Phone: 09123783823

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place