Missed Abortion Clinical Trial
Official title:
Misoprostol Plus Isosorbide Mononitrate Versus Misoprostol For Termination Of Anembryonic Pregnancy
NCT number | NCT02573051 |
Other study ID # | ANP |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | October 8, 2015 |
Last updated | October 8, 2015 |
Start date | June 2015 |
Verified date | October 2015 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 108 |
Est. completion date | |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut university | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months | Yes |
Secondary | Induction - abortion interval in hours | The period from the start of administration of misoprostol until complete abortion | 6 months | Yes |
Secondary | 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 | 6 month | Yes |
Secondary | The occurrence of sever uncontrolled lower abdominal pain by visual analogue scale | 6 months | Yes |
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