Isosorbide Mononitrate in Induction of Labour | NCT04482881

Studies
Isosorbide Mononitrate in Induction of Labour

NCT04482881

Sponsor

Aljazeera Hospital

Status

Unknown status

Last Update Posted

Jul 23, 2020Actual

Enrollment

130Estimated

Phase

Early Phase 1

Conditions

Labor Fast

Interventions

Isosorbide Mononitrate 40 MG
Isosorbide Mononitrate 60 MG
Misoprostol

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

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2020Estimated

Primary Completion Date

Sep 20, 2020Estimated

Completion Date

Sep 25, 2020Estimated

First Submitted Date

Jul 19, 2020

First Submission Date that Met QC Criteria

Jul 19, 2020

First Posted Date

Jul 23, 2020Actual

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

Jul 19, 2020

Last Update Posted Date

Jul 23, 2020Actual

Name	Class
Suez Canal University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Induction of labor is defined as the process of artificially initiating uterine contractions, prior to their spontaneous onset, with progressive effacement and dilatation of the cervix and ultimately, the delivery of the baby.

Detailed Description

There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common cause.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
women receiving isosorbide mononitrates lower dose	Active Comparator	women who will receive isosorbide mononitrates lower dose	Drug: Isosorbide Mononitrate 40 MG
women receiving isosorbide mononitrates higher dose	Active Comparator	women who will receive isosorbide mononitrates higher dose	Drug: Isosorbide Mononitrate 60 MG
Women receiving misoprostol	Active Comparator	Women who will receive misoprostol	Drug: Misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Isosorbide Mononitrate 40 MG	Drug	giving women isosorbide mononitrate 40 MG	women receiving isosorbide mononitrates lower dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the number of women who will be reach active phase within 24 hours	how many women will reach active phase within 24 hours	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Single vertex presentation. 2. Gestational age > 37weeks calculated from last menstrual period or U/S scanning.

Exclusion Criteria:

Patients with rupture of membranes.
Previous uterine scar.
Fetal malpresentation.
Multiple pregnancies.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Alalfy	Contact	01002611058		mahmoudalalfy@ymail.com

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy, PhD	Algezeera hospitaland National Research Centre ,Egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah		Giza			Egypt	Mahmoud Alalfy, master

Intervention Browse Module

MeSH Terms

ID	Term
C030397	isosorbide-5-mononitrate
D016595	Misoprostol

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided