Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical R... | NCT03544606

Studies
Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor

NCT03544606

Sponsor

ahmed nagy shaker ramadan

Status

Completed

Last Update Posted

Aug 22, 2024Actual

Enrollment

160Actual

Phase

Phase 4

Conditions

Induction of Labor Affected Fetus / Newborn

Interventions

isosorbide mononitrate
Placebos

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Jun 15, 2024Actual

Completion Date

Jun 30, 2024Actual

First Submitted Date

May 18, 2018

First Submission Date that Met QC Criteria

May 31, 2018

First Posted Date

Jun 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2024

Last Update Posted Date

Aug 22, 2024Actual

Name	Class
Kafrelsheikh University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor.

Research Hypothesis:

In women undergoing induction of labor, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery.

Research Questions:

Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor?

Detailed Description

Type of Study : Prospective double blind randomized controlled clinical trial.
Study Setting : This study will be conducted in Kafr Elsheikh University maternity hospital.
Study Period : Expected 6 months from December 2023 to June 2024.
Study Population : Patients will be recruited in this study those attending labor ward at Kafr Elsheikh hospital for induction of labor at term or post-term with unripe cervix (Bishop Score ˂ 6).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
isosorbide mononitrate group	Experimental	In vaginal IMN group (group 1) 40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses.	Drug: isosorbide mononitrate
placebos group	Placebo Comparator	In the placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
isosorbide mononitrate	Drug	40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
admission-delivery interval	The time from initiation labor induction and delivery of placenta	up to 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton pregnancy.
Cephalic presentation.
Bishop score < 6.
Average size of the fetus.
Adequate pelvic dimensions.
Term or post-term pregnancies with an indication for labor induction either maternal or fetal.

Exclusion Criteria:

• Previous uterine scar.
- Patients with regular uterine contractions.
- Malpresentation.
- Multifetal gestation.
- Prelabour rupture of membranes.
- Established fetal distress.
- Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia.
- Antepartum hemorrhage.
- Active genital herpes infection.
- Severe maternal illness (e.g. severe preeclampsia).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed N Shaker, MD	faculty of medicine - Kafr elsheikh university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
faculty of medicine - Kafr Elsheikh university		Kafr ash Shaykh			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

The data supporting this research is available upon request. Please contact corresponding Author at ahmedafifi38527@postgrad.kasralainy.edu.eg for access to the relevant datasets. We are committed to transparency and facilitating the reproducibility of our findings, and we welcome inquiries regarding the data used in this study.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C030397	isosorbide-5-mononitrate
D011736	Pyridoxine

Ancestor Terms

ID	Term
D025101	Vitamin B 6
D010847	Picolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

The patients will be divided into 2 groups.

Group 1:

80 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM)

Group 2:

80 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.

Masking Info

Masking

Double

Masking Description

To insure that everyone has the chance of participation, Randomization will be done using computer generated randomization sheet using statsdirect version 3. Double blinding will be done by one of the supervisors who will be the only one to know the key, thus the care provider and the patient will not know is it the drug or the placebo.

Who Masked

ParticipantCare Provider