IRCT | Safety and efficacy of cervical administration of misoprostol in induction of labor in mothers with unripe cervix and term pregnancy compared to vaginal and sublingual administration: a randomized clinical trial.

Protocol summary

Study aim: Comparing the effect of cervical misoprostol with vaginal and sublingual misoprostol in induction of labor in mothers with unripped cervix and term pregnancy.
Design: A randomized, single-blind clinical trial with three parallel groups on 123 people. Stratified block randomization is done using Sealedenvelop.com software.
Settings and conduct: The study will be conducted in the delivery ward of Akbarabadi Hospital. Eligible patients, after obtaining informed consent, will undergo induction of labor by prescribing misoprostol by one of the three intracervical, sublingual, or vaginal routes (41 people in each group). Maternal and neonatal outcomes will be evaluated. The outcome assessor and data analyzer were blinded to the assigned groups.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Women aged 18-40 years old, singleton pregnancy with appropriate weight and Bishop score less than or equal to 6. Exclusion criteria: high-risk pregnancies.
Intervention groups: Intervention group with intracervical misoprostol, sublingual misoprostol, and vaginal misoprostol,
Main outcome variables: Time to reach active labor phase, time lag to delivery and neonatal Apgar

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200421047152N4

Registration date: 2023-10-11, 1402/07/19

Registration timing: prospective

Last update: 2023-10-11, 1402/07/19

Update count: 0
Registration date: 2023-10-11, 1402/07/19

Registrant information: Name

Arash Mohazzab

Name of organization / entity

Avicenna Research Institute

Country

Iran (Islamic Republic of)

Phone

+98 21 2351 9630

Email address

amohazzab@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-10-17, 1402/07/25
Expected recruitment end date: 2024-03-10, 1402/12/20
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Safety and efficacy of cervical administration of misoprostol in induction of labor in mothers with unripe cervix and term pregnancy compared to vaginal and sublingual administration: a randomized clinical trial.

Public title: Safety and efficacy of cervical administration of misoprostol in induction of labor compared to vaginal and sublingual administration
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Women aged 18-40 years Singleton pregnancy Cephalic presentation Gestational age more than 37 weeks Appropriate pelvic examination Intact membranes Fetal weight between 90-10th percentile estimated by ultrasound ishop score less than or equal to 6

Exclusion criteria:

Birth history equal to or more than 3 Blood pressure equal to or greater than 140/90 mmHg Proteinuria or preeclampsia Getational diabetes Unreliability of fetal heart trace or any fetal distress Polyhydramnios or oligohydramnios The possibility of fetal macrosomia Intrauterine fetal death Previous history of uterine surgery Bleeding Placenta previa
Age: From 18 years old to 40 years old
Gender: Female

Phase

3

Groups that have been masked

Outcome assessor
Data analyser

Sample size

Target sample size: 123

Randomization (investigator's opinion)

Randomized

Randomization description

The candidates will be allocated into groups in a stratified randomization method (based on the history of parity) with a permutation block of 6 using a randomization list generated by the Sealedenvelope.com website software. The randomly generated sequence will be placed one by one in opaque closed envelopes and after writing the codes on it, it will be given to the third person in the delivery block, and will be opened after the entry of each volunteer and the group of that person will be specified.

Blinding (investigator's opinion)

Single blinded

Blinding description

Study outcomes will be assessed by someone other than the intervention assignor. The information of the three groups will be provided to the statistical analyst in coded form so that they are not aware of the intervention groups.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

IUMS Biomedical Research Ethics Committee

Street address

Next to Milad Tower, Hemmat

City

Tehran

Province

Tehran

Postal code

۱۴۴۹۶۱۴۵۳۵
Approval date: 2022-11-23, 1401/09/02
Ethics committee reference number: IR.IUMS.REC.1402.604

Health conditions studied

1

Description of health condition studied: Labour induction
ICD-10 code: O61
ICD-10 code description: Failed induction of labour

Primary outcomes

1

Description: Time to reach active labour phase
Timepoint: Immediately after intervention
Method of measurement: Physical examination

Secondary outcomes

1

Description: Time to delivery
Timepoint: Between intervention and delivery
Method of measurement: Clinical examination

2

Description: Percentage of cesarean section
Timepoint: 24 hours after intervention
Method of measurement: Clinical assessment

3

Description: Neonatal apgar
Timepoint: First and fifth minutes after delivery
Method of measurement: clinical assessment

Intervention groups

1

Description: Intervention group with intracervical misoprostol: In this group, 25 micrograms of intracervical misoprostol is prescribed to induce labor. If appropriate contractions are not reached, misoprostol is repeated with the same dose every four hours. This process continues until at least three contractions with adequate strength with a duration between 40-60 seconds occur within ten minutes or four doses of misoprostol are repeated.
Category: Treatment - Drugs

2

Description: Intervention group: Intervention group with sublingual misoprostol: In this group, 25 micrograms of sublingual misoprostol is prescribed to induce labor. If appropriate contractions are not reached, misoprostol is repeated with the same dose every four hours. This process continues until at least three contractions with adequate strength with a duration between 40-60 seconds occur within ten minutes or four doses of misoprostol are repeated.
Category: Treatment - Drugs

3

Description: Intervention group: Intervention group with vaginal misoprostol: In this group, 25 micrograms of vagianl misoprostol is prescribed to induce labor. If appropriate contractions are not reached, misoprostol is repeated with the same dose every four hours. This process continues until at least three contractions with adequate strength with a duration between 40-60 seconds occur within ten minutes or four doses of misoprostol are repeated.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Shahid Akbarabadi hospital

Full name of responsible person

Dr. Nooshin Eshraghi

Street address

Bagh ferdous station, Molavi St.

City

Tehran

Province

Tehran

Postal code

1168743514

Phone

+98 21 5560 6034

Fax

+98 21 5560 8012

Email

eshraghi.n@iums.ac.ir

1

Sponsor: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Reza Falak

Street address

Next to Milad Tower, Hemat Highway

City

Tehran

Province

Tehran

Postal code

۱۴۴۹۶۱۴۵۳۵

Phone

+98 21 86701

Email

falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Iran University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Nooshin Eshraghi

Position

Associated professor

Latest degree

Subspecialist

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Bagh ferdous station, Molavi St.

City

Tehran

Province

Tehran

Postal code

1168743514

Phone

+98 21 5560 6034

Email

eshraghi.n@iums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Nooshin Eshraghi

Position

Associated professor

Latest degree

Subspecialist

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Bagh ferdous station, Molavi St.

City

Tehran

Province

Tehran

Postal code

1168743514

Phone

+98 21 5560 6034

Email

eshraghi.n@iums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Iranian academic center for education culture and research

Full name of responsible person

Arash Mohazzab

Position

PhD

Latest degree

Specialist

Other areas of specialty/work

Epidemiology

Street address

Yakhchal Junction, Shariati street

City

Tehran

Province

Tehran

Postal code

1941913114

Phone

+98 21 2351 9630

Fax

Email

amohazzab@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Not applicable
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Safety and efficacy of cervical administration of misoprostol in induction of labor in mothers with unripe cervix and term pregnancy compared to vaginal and sublingual administration: a randomized clinical trial.