Termination Of Anembryonic Pregnancy
Primary Purpose
Missed Abortion
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Isosorbide mononitrate
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Missed Abortion
Eligibility Criteria
Inclusion Criteria:
- Maternal age ≥20years old.
- No vaginal bleeding.
- No dilation of internal os.
- Gestational age: from 8-11weeks.
- Gestational sac with a mean gestational sac diameter (MGD) greater than 25 mm and no yolk sac, or an MGD >25 mm with no embryo.
Exclusion Criteria:
- Patients with excessive vaginal bleeding (soaking more than a pad per day).
- Patients with dilated cervix.
- Patients with allergy either to misoprostol or isosorbide mononitrate.
- Those who will be insisted on D and C will be excluded from the study.
- Women will be excluded from the study if they are anemic (hemoglobin less than 11 g/dl).
- Hemo-dynamically unstable with signs of pelvic infection and/or sepsis.
- Suffering from a clotting disorder or using anticoagulants.
- Women with uterine pathology such as myomas or malformation.
- Women had previous caesarian section.
- Asthmatic patients.
Sites / Locations
- Assiut universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Misoprostol plus isosorbide mononitrate
Misoprostol plus placebo
Arm Description
this group will receive 800 µg of misoprostol (Misotac 200 µg Sigma for Pharmaceutical Industries) plus 40 mg isosorbide mononitrate (Effox 40 mg Minipharma Company) will be inserted into the posterior vaginal fornix
This group will receive misoprostol 800 µg plus placebo in the same site.
Outcomes
Primary Outcome Measures
The measurement of endometrial thickness by ultrasound in mm
Complete expulsion of remnant of conception is considered if endometrial thickness less than 10 mm and if more than 10 mm it considered incomplete expulsion.
Secondary Outcome Measures
Induction - abortion interval in hours
The period from the start of administration of misoprostol until complete abortion
Induction dilatation interval in hours
The period from the start of administration of misoprostol until the start of cervical dilatation measured during per vagina (P/V) examination
The occurrence of sever uncontrolled lower abdominal pain by visual analogue scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02573051
Brief Title
Termination Of Anembryonic Pregnancy
Official Title
Misoprostol Plus Isosorbide Mononitrate Versus Misoprostol For Termination Of Anembryonic Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Anembryonic pregnancy is a leading cause of early miscarriage. The American Pregnancy Association estimates that blighted ovum causes approximately 50 percent of all first-trimester miscarriages. About 20 percent of all pregnancies result in miscarriage.
In general, there are 3 options for management of anembryonic pregnancy: expectant, medical, and surgical management. Expectant management consists of no intervention and awaiting natural passage of tissue. Medical management uses medication to expel uterine tissue. Surgical management is defined by mechanical removal of tissue from the uterus.
Medical management allows patients to avoid surgery and anesthesia. Patients may also feel that medical management is more private, and under their control. Several medications have been studied for medical management.
Misoprostol, a prostaglandin E1 analogue, is a uterotonic that results in cervical softening and contractions that expel the products of conception. It may be administered vaginally, orally, buccally, or sublingually. Adverse effects vary based on route of administration.
There is published literature on a wide range of therapeutic misoprostol regimens. Optimal dose and route of administration of misoprostol have not been determined by randomized trials. Overall, misoprostol is safe and well-tolerated.
Patients receiving misoprostol vaginally rather than orally have decreased adverse gastrointestinal effects and prolonged duration of action.
Oral misoprostol is less effective than vaginal misoprostol in emptying the uterus. Sublingual misoprostol is equivalent to vaginal misoprostol in inducing complete uterine emptying but is associated with more frequent diarrhea.
When compared with lower dosages, a dose of 800 µg vaginal misoprostol is more effective at completing uterine emptying, although it results in a similar incidence of nausea. Based on international trials in settings with limited resources, WHO recommends a single vaginal dose of 800 µg misoprostol for medical management of anembryonic pregnancy. Routes of misoprostol administration include oral, vaginal, buccal or rectal. Vaginal misoprostol is associated with a greater overall exposure to the drug and greater effects on the cervix and uterus.
Isosorbide mononitrate (IMN) is a drug used principally in the treatment of angina pectoris, which acts by dilating the blood vessels so as to reduce blood pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missed Abortion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Misoprostol plus isosorbide mononitrate
Arm Type
Active Comparator
Arm Description
this group will receive 800 µg of misoprostol (Misotac 200 µg Sigma for Pharmaceutical Industries) plus 40 mg isosorbide mononitrate (Effox 40 mg Minipharma Company) will be inserted into the posterior vaginal fornix
Arm Title
Misoprostol plus placebo
Arm Type
Active Comparator
Arm Description
This group will receive misoprostol 800 µg plus placebo in the same site.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
800 µg of misoprostol (Misotac 200 µg Sigma for Pharmaceutical Industries)
Intervention Type
Drug
Intervention Name(s)
Isosorbide mononitrate
Intervention Description
40 mg isosorbide mononitrate (Effox 40 mg Minipharma Company)
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
The measurement of endometrial thickness by ultrasound in mm
Description
Complete expulsion of remnant of conception is considered if endometrial thickness less than 10 mm and if more than 10 mm it considered incomplete expulsion.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Induction - abortion interval in hours
Description
The period from the start of administration of misoprostol until complete abortion
Time Frame
6 months
Title
Induction dilatation interval in hours
Description
The period from the start of administration of misoprostol until the start of cervical dilatation measured during per vagina (P/V) examination
Time Frame
6 month
Title
The occurrence of sever uncontrolled lower abdominal pain by visual analogue scale
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Maternal age ≥20years old.
No vaginal bleeding.
No dilation of internal os.
Gestational age: from 8-11weeks.
Gestational sac with a mean gestational sac diameter (MGD) greater than 25 mm and no yolk sac, or an MGD >25 mm with no embryo.
Exclusion Criteria:
Patients with excessive vaginal bleeding (soaking more than a pad per day).
Patients with dilated cervix.
Patients with allergy either to misoprostol or isosorbide mononitrate.
Those who will be insisted on D and C will be excluded from the study.
Women will be excluded from the study if they are anemic (hemoglobin less than 11 g/dl).
Hemo-dynamically unstable with signs of pelvic infection and/or sepsis.
Suffering from a clotting disorder or using anticoagulants.
Women with uterine pathology such as myomas or malformation.
Women had previous caesarian section.
Asthmatic patients.
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Ali, MD
Phone
+0201005537951
Email
m_khairy2001@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Termination Of Anembryonic Pregnancy
We'll reach out to this number within 24 hrs