Misoprosotol and Isosorbide Mononitrate for Induction of... | NCT03407521

Studies
Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

NCT03407521

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Feb 28, 2018Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Second Trimester Abortion

Interventions

Misoprostol
isosorbide mononitrate
Placebo

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

Feb 2018

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

Apr 12, 2017Actual

Primary Completion Date

Oct 22, 2017Actual

Completion Date

Dec 15, 2017Actual

First Submitted Date

Jan 16, 2018

First Submission Date that Met QC Criteria

Jan 22, 2018

First Posted Date

Jan 23, 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

Feb 26, 2018

Last Update Posted Date

Feb 28, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed abd elfatah elsenity, lecturer MD, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

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

the investigators aimed to study the efficacy and safety of nitric oxide donors when combined with prostaglandins in induction of second trimester abortion expecting that both drugs when used together will be of greater efficiency and associated with less side effects.

the study included 60 women with gestational age between 13weeks+0day and 26weeks+6days indicated for pregnancy termination due to maternal or fetal cause.

Detailed Description

the study aimed to compare the effect of isosorbid mononitrate when combined with misoprostol and misoprostol when used alone in second trimester abortion, expecting that both drugs when used together will be more effective and associated with fewer side effects.

In this study 60 women were enrolled, divided into two groups. The first group (group I), 30 women received misoprostol and isosorbid mononitrate.

The second group (group II), 30 women received misoprostol and placebo. The primary aim of the study was the occurrence of complete abortion in the first 24 hours.

The study concluded that the combination of isosorbid mononitrate with misoprostol is more effective in second trimester abortion than misoprostol with placebo, but is associated with more side effects mainly headache.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Active Comparator	misoprostol tab 200mcg 2 tab at first then one every 4 hours with isosorbide mononitrate 20mg once	Drug: Misoprostol Drug: isosorbide mononitrate
control group	Placebo Comparator	misoprostol tab 200mcg 2 tab at first then one every 4 hours with placebo	Drug: Misoprostol Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug	induction of abortion using misoprostol	control group study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
induction abortion interval	time needed to induce abortion in second trimester abortion	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 16 -40 years
Missed abortion
Singelton pregnancy
Gestationl age between 13 and 26 weeks of pregnancy
Normal uterus and cevix on clinical examination
Cervix is not dilatated
No uterine activity and vaginal bleeding
Written and informed consent by the patient
Unscarred uterus

Exclusion Criteria:

Presence of uterine contraction or bleeding
Evidences suggesting of onset of spontaneous abortion as Previous trial to induce abortion
Multifetal pregnancy
Suspicion of septic abortion
History of cervical surgery or manipulation
Uterine anomaly
IUD in situ
Associtaed hemorrhagic disorder
History of adverse effects to vaginally adminstered medication
Inability to insert vaginal medication high in vagina

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mohamed ab elsenity, MD	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Ain Shams University		Cairo		11566	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8694046	Result	Jain JK, Mishell DR Jr. A comparison of misoprostol with and without laminaria tents for induction of second-trimester abortion. Am J Obstet Gynecol. 1996 Jul;175(1):173-7. doi: 10.1016/s0002-9378(96)70270-3.

ID	Term
D016595	Misoprostol
C030397	isosorbide-5-mononitrate

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